Market · Life sciences talent
Cell and gene therapy regulatory counsel.
Two European instruments landed inside three weeks of January 2025 and turned an advanced-therapy company's regulatory work into a dated calendar that runs from manufacturing comparability to a single European payer dossier. The calendar has an owner for every line and, in most companies, nobody who owns the join.
Who owns the filing calendar once the therapy is in the clinic?
A company with a cell and gene therapy in development is no longer making ad hoc submissions; it is running a dated calendar. Across 250 structured interviews with Boston lawyers and legal leaders, the 68 respondents sitting in-house at biotech, cell-therapy and contract-manufacturing employers over a 24-month window told Sartori the calendar had an owner for every individual line and no owner for the join.
From 12 January 2025, on the European Commission’s own implementation page, the Joint Clinical Assessment applies to new cancer medicines and advanced therapy medicinal products first. The clinical evidence is assessed once, centrally, on a timetable that now overlaps the marketing-authorization file. One dossier, two audiences, one clock.
The obligations are dated and public; the seat that answers them is neither. Where the seat actually sits, and what it is called, is set out below.
- 12 Jan 2025
- Joint Clinical Assessment applies to advanced therapiesCancer medicines and ATMPs were the first two categories in scope
- European Commission, JCA implementation page
- 30 Jan 2025
- Clinical Trials Regulation transition closedLegacy Directive trials CTIS-compliant from 31 January 2025
- euclinicaltrials.eu; European Medicines Agency
- 52
- FDA-approved cellular and gene therapy productsAgency list current as of 18 August 2026
- FDA, Office of Therapeutic Products
- 3
- Joint Clinical Assessment reports published to dateAll oncology medicines; none an advanced therapy, as of 3 September 2026
- European Commission, HTA key documents
The rule arrived on a date. The job title did not.
Three weeks of January 2025 rewrote what an advanced-therapy company has to produce and when. Neither instrument created a seat, and that omission is the buyer's problem rather than the regulator's.
Regulatory work for a living medicine used to be described as a posture: engage the agency early, keep the quality system in order. Since January 2025 it is a calendar. The European Union’s health technology assessment regime and its clinical trials regime both reached their operative dates inside the same month, converting a set of professional habits into dated deliverables with named recipients. A filing calendar with an owner for every line and no owner for the join is not a staffing gap; it is a single point of failure with a date on it.
The first date is 12 January 2025. On the European Commission’s implementation page, the Joint Clinical Assessment under the health technology assessment Regulation applies from that day to new medicines for the treatment of cancer and to advanced therapy medicinal products — those two categories ahead of everything else. The Regulation entered into force on 11 January 2022, so the sector had three years of notice. The mechanism is easy to describe and uncomfortable to staff: a developer filing a marketing-authorization application from that date sends the summary of product characteristics and the clinical overview to the assessment secretariat, scoping opens, and the clinical evidence is assessed once for all member states rather than twenty-seven times. Pricing stays national. The evidence does not.
The second date is 30 January 2025. The Clinical Trials Regulation replaced the old Directive with a three-year transition that, on the Clinical Trials Information System guidance pages, ran from 31 January 2022 until the end of the transitional period on 30 January 2025. The European Medicines Agency describes the same cutover from the other side: from 31 January 2025, any trial approved under the Directive and still running had to comply with the Regulation and be recorded in CTIS. For a cell or gene therapy with a long open-label follow-up that is not paperwork. It is a protocol, a sponsor position and a public register entry, and someone has to sign each of them.
What an advanced therapy medicinal product is, in law
The category is not a marketing term. Under Regulation (EC) 1394/2007, as the European Medicines Agency sets it out, an advanced therapy medicinal product is a gene therapy medicine, a somatic-cell therapy medicine or a tissue-engineered medicine, with a fourth combined class that incorporates a medical device as an integral component. That fourth class is where a legal function earns its place, because a combined product drags device law, supplier agreements and a second conformity route into a file the science team reads as one product.
The consequence is not about volume. It is consistency across documents that different functions own. The label claim, the clinical overview sent to the assessment secretariat, the CTIS record, the comparability package behind a manufacturing change and the development and manufacturing agreement that decides who owns the data in it all have to say the same thing on the same dates. Regulatory affairs writes most of them. Legal owns the contracts underneath them. Neither owns the calendar that binds them, which is why a general counsel usually reads about a problem after a submission has gone out.
Filed inside regulatory affairsOwned inside the legal function
- Regulatory affairs files it The submission, the agency dialogue and the dossier sit with the people who write them. Legal is consulted at signature and reads the calendar as a science schedule.
- Nobody is named The commonest arrangement. Each document has an author, the joins between them have none, and the failure shows up as an inconsistency rather than as a missed date.
- Legal owns the calendar A named counsel holds the sequence, the contract chain that feeds it and the disclosure that follows it, and regulatory affairs keeps the technical file. Rare, and usually built after a deficiency letter.
Sartori’s record in this city says the same from the buying side. Of the 19 closed Boston in-house searches on our book over the trailing three years, 6 were regulatory or regulatory-adjacent seats at advanced-therapy developers and contract manufacturers, and 4 of those six opened only after a filing date had already been set. Six files inside nineteen, over thirty-six months. Companies do not underestimate the work; they cannot see it as a single object until an external date forces them to.
A filing calendar with an owner for every line and no owner for the join is not a staffing gap; it is a single point of failure with a date on it.
Six dated items now sit on one advanced-therapy legal year.
Each item has an instrument behind it, a date attached and a function that has to produce the document. Not one of them is a single filing, and two of them are squarely legal work rather than regulatory work.
The calendar is not evenly distributed across the year or across functions. Two items are regulatory affairs with a legal consequence; two are legal with a regulatory trigger; two are shared, and the shared ones are the ones that fail. Writing the list down is the first useful thing a general counsel can do with it, because a schedule is fundable in a way that a job title is not.
The United Kingdom items deserve their own line. On the Cell and Gene Therapy Catapult’s November 2025 regulatory round-up, the MHRA’s new Phase 1 clinical-trial insurance requirements take effect on 28 April 2026: sponsors must provide proof of insurance with Research Ethics Committee applications covering investigator and sponsor liability, and non-NHS Phase 1 sites must independently verify that cover and document the review in the trial file. That is not a scientific obligation. It is insurance, contract and record-keeping work with a regulatory deadline, and it is the cleanest example on this page of why the seat is legal as well as technical. The same round-up records the MHRA’s commitment of 2 November 2025 to a framework overhaul for rare-disease and advanced therapies, due in 2026 — a rule that does not exist yet and already generates work.
| Item | What triggers it | Date | Who is on the hook | What it produces |
|---|---|---|---|---|
| Joint Clinical Assessment | An EMA marketing-authorization application for a new cancer medicine or an advanced therapy medicinal product | 12 January 2025 (European Commission) | Regulatory affairs files it; legal owns consistency between the label, the evidence claims and the contracts underneath | A scoping submission, then one clinical assessment used by every member state |
| Clinical Trials Regulation compliance | A trial authorized under the old Clinical Trials Directive and still running at the end of the transition | Transition closed 30 January 2025; CTIS compliance from 31 January 2025 (euclinicaltrials.eu; EMA) | Clinical operations and legal jointly: the sponsor position is a legal one | A transitioned protocol, a complete CTIS record and a documented sponsor decision |
| Manufacturing comparability | A process, site, scale or supplier change to a living product | Continuous, and carried into every filing above it | Quality and CMC, with legal on the contract chain to the manufacturer | A comparability package and the contractual right to the data that supports it |
| UK Phase 1 insurance verification | A Phase 1 application to a Research Ethics Committee, and any non-NHS Phase 1 site | 28 April 2026 (MHRA, reported by CGT Catapult) | Legal, squarely: proof of cover, site verification, trial-file documentation | Evidence of investigator and sponsor liability cover, verified and filed |
| UK rare-disease framework overhaul | An MHRA commitment to rewrite the evidence, quality and surveillance framework | Committed 2 November 2025, framework due in 2026 (MHRA, reported by CGT Catapult) | Regulatory affairs leads; legal writes the consultation position | A response to a framework that does not exist yet, and a revised evidence plan |
| Post-market safety programme | A safety signal that produces label restriction and a mandated study | Following FDA action in June and July 2025 (CGT Catapult) | Legal and pharmacovigilance, with disclosure obligations attached | A Boxed Warning, a restricted indication and a 200-patient observational study with its own reporting calendar |
Two further instruments sit alongside the six and are worth naming without explaining. The European Commission proposed the Critical Medicines Act in March 2025, carrying strategic project designation, joint procurement and supply-chain diversification — a manufacturing track parallel to the clinical one. The United Kingdom published its Life Sciences Sector Plan on 16 July 2025, stating an ambition to be the leading life sciences economy in Europe by 2030. A company with a Basel manufacturing footprint and a London clinical site tracks both alongside the six.
Approvals kept coming through the same window, which is what separates a compliance transition from a slowdown. The FDA’s list of approved cellular and gene therapy products stood at 52 on a page current as of 18 August 2026, and the agency approved KRESLADI, a gene therapy for pediatric severe leukocyte adhesion deficiency-I, on 26 March 2026. In November 2025, on the same CGT Catapult round-up, the European Medicines Agency recommended approval of a Wiskott-Aldrich gene therapy and NHS England made a CAR-T therapy available from 25 November 2025 through specialist centers. The workload after January 2025 was additive. Nothing was traded away.
Where cell and gene therapy regulatory counsel actually sits.
Across the leadership pages checked for this piece, the legal function is one centralized officer and the cell-therapy business is a separate organization. Neither chart shows the person who owns the calendar between them.
Start with what employers publish about themselves, because it is the only org-chart evidence that is not anecdote. Bristol Myers Squibb’s leadership roster carries a President, Cell Therapy Organization as a distinct business-unit seat and, separately at corporate level, an Executive Vice President, General Counsel and Chief Policy Officer; there is no chief regulatory officer on it. CRISPR Therapeutics, dual-headquartered in Boston and in Zug, publishes General Counsel and Secretary as its only legal C-suite title. Roche, headquartered in Basel, lists a single General Counsel on its Group Executive Committee, with no regulatory equivalent.
Three leadership pages are a pattern, not a census, and should be read as exactly that. What they show consistently is a shape: legal centralized in one officer, the advanced-therapy business organized separately, and no coordination point between them at executive level. The person who owns the filing calendar sits below the published line — which is why the requisition, when it appears, is written by somebody who has never had to name the role before.
The one public title that comes closest is a fusion. REGENXBIO, a listed adeno-associated virus gene-therapy company, discloses an EVP, Chief Strategy and Legal Officer in the proxy statement it filed with the SEC on 14 April 2026 — one seat holding both functions. At the scale where a gene-therapy company has a near-commercial asset and cannot yet carry two officers, the calendar and the contracts go on the same person, because the alternative is to put them on nobody.
| Employer shape | Where the calendar sits today | What the legal seat is called | What the buyer is really paying for |
|---|---|---|---|
| Large-cap pharma with a marketed cell-therapy franchise | Inside a dedicated business unit, with corporate legal centralized elsewhere | No dedicated title. Bristol Myers Squibb publishes a President, Cell Therapy Organization and, separately, an EVP, General Counsel and Chief Policy Officer | Coordination across two org charts that do not report to each other |
| Clinical-stage developer | With regulatory affairs, reporting into R&D, with legal consulted at filing | General Counsel, usually the only legal officer. CRISPR Therapeutics publishes General Counsel and Secretary as its sole legal title | A first specialist hire under a generalist head of legal |
| Contract development and manufacturing organization | With quality, and with the commercial team that signs the client agreement | Counsel to a manufacturing business, not to a sponsor | Someone who reads a comparability obligation as a contract term, not a science question |
| Post-approval company under private-equity ownership | Wherever the leaner structure left it | Often fused. REGENXBIO discloses an EVP, Chief Strategy and Legal Officer in its 2026 proxy | One person carrying strategy, legal and the surviving post-approval obligations |
One person carries itA panel carries it
- The fused officer Strategy, legal and the surviving post-approval obligations on one title. Fast to decide, and a single resignation away from an empty calendar.
- The split seat A specialist counsel under a generalist head of legal, with regulatory affairs keeping the technical file. What most companies actually need and few write down.
- Coordinator plus panel An internal coordinator instructing outside counsel by workstream. Defensible for one application; expensive and slow once the calendar repeats.
The law-firm market answers the same way from the other direction, and it is context rather than the argument. Covington & Burling files this work under Pharma and Biotech, one of six sub-areas of its Food, Drug, and Device practice; Sidley Austin markets a single integrated life sciences practice spanning regulatory, corporate and litigation. Neither publishes a standalone cell-and-gene-therapy practice brand. If the external market has not branded the specialism, the internal market has no title to copy, and the requisition gets written from scratch every time.
A general counsel at a Boston-area clinical-stage cell-therapy developer, interviewed inside the same cohort, put the failure precisely: the company had an owner for every document on the calendar and no owner for the order they went out in. A head of legal at a European-headquartered contract development and manufacturing organization with a Massachusetts site described the mirror image — the comparability file was the only document three functions edited and none owned, and the client contract was silent on which of them had to sign it.
Two adjacent seats are worth naming so this page is not mistaken for them. Life-sciences licensing and collaboration counsel papers the collaboration and the platform license, and is a different hire. Med-tech and digital-health regulatory counsel answers to device regulation and its own conformity routes, and is a different hire again. Whether life sciences legal hiring is up or down is answered on our life sciences hiring read for 2026, which owns that argument and its mapping counts.
The credential that matters here is a filing history, not a certificate, because no certificate covers it.
One disclosed number, and no published band.
No compensation survey isolates this seat. What exists is a proxy statement, a capital cycle, a labor-market trough with a rebound behind it, and a search book with its own measured windows.
The credential that matters here is a filing history, not a certificate, because no certificate covers it. That has a direct consequence for price: a company cannot benchmark the seat against a qualification, so it benchmarks it against the reporting line, and the reporting line is the variable that actually moves the number.
Start with the only dated, public, company-specific figure available. In the proxy statement REGENXBIO filed with the SEC on 14 April 2026, its EVP, Chief Strategy and Legal Officer received total fiscal-2025 compensation of $2,041,511 — salary of $520,903, a $200,000 cash bonus described as transaction-related and tied to a collaboration agreement effective March 2025, and $1,096,810 of option awards, with no stock awards. The prior proxy, filed 8 April 2025, shows the same seat at $2,737,813 for fiscal 2024, weighted the other way: $500,868 of salary, no bonus, $1,386,135 of stock and $628,120 of options. Two filings, one company, one fused officer title.
Below officer level no band exists, and this page does not invent one. What can be described is how the package is set. It is anchored on the general in-house benchmark for the market and the company stage — our in-house counsel salary read for 2026 carries that reference — and then moved by three things: whether the seat reports to the general counsel or to the head of regulatory affairs, whether it carries signature authority on submissions, and whether the equity is priced against an approved product or a first application pending. A counsel reporting into regulatory affairs is priced as a manager; the same person under the general counsel is priced as counsel, and that gap is larger than any adjustment for years of experience.
The capital behind the seat is dated and uneven. uniQure priced an underwritten public offering of 4,411,764 ordinary shares at $17.00 for approximately $75 million in gross proceeds, expected to close on 10 January 2025, on the 8-K it filed with the SEC on 8 January 2025 — the same month the trials transition closed. Across 2025, SEC filings show at least six separate Nasdaq-listed gene-therapy issuers running offering-related 8-Ks, several of them more than once. No aggregate dollar figure is published and none is asserted here; the count establishes that the sector financed itself repeatedly through public equity in the year the calendar started.
Boston’s own market ran the other way at the same time. MassBio’s 2026 Industry Snapshot records Massachusetts biopharma employment contracting 3.1 percent during 2025 to 113,503 jobs, the first annual decline in more than twenty years of the association’s tracking. Massachusetts-headquartered companies then raised $3.45 billion of venture funding in the first half of 2026, up 25 percent year on year and equal to a quarter of all United States biopharma venture capital, in the same report. The two figures cover different periods and should not be added. In sequence they describe a trough with capital arriving behind it.
The clearest evidence that this seat does not track company headcount comes from the same year. Sarepta Therapeutics cut roughly 500 roles, about 36 percent of its workforce, in July 2025 — the month the FDA placed Elevidys on clinical hold on the 18th, the CHMP recommended against European authorization on the 25th, and the hold was lifted for ambulatory patients on the 28th. The obligations on that product then expanded: on the Cell and Gene Therapy Catapult’s November 2025 round-up, the FDA added a Boxed Warning, restricted the indication to ambulatory patients aged four and over, and mandated a prospective 200-patient observational study for hepatotoxicity with its own multi-year reporting calendar. Headcount fell by a third while the compliance workload on the flagship product grew.
Ownership change does the same thing more quietly. bluebird bio, registered in Somerville and one of the city’s founding gene-therapy companies, filed its last annual report for the year ended 31 December 2024 with the SEC on 27 March 2025 and was taken private by Carlyle and SK Capital in June 2025, re-emerging as Genetix Biotherapeutics. Approved products carry post-approval obligations that survive a change of control intact; the calculus about carrying them inside does not.
Four to seven months, and the scope is the reason.
This search runs long because the requisition asks one person to be two pipelines at once, and because the counter-offer arrives from an employer who has only just understood what the seat was protecting.
The measurable part first. Sartori has worked the Boston market for eight years and closed 19 in-house searches there across the trailing three years, with a 93 percent completion rate and a typical timeline of four to seven months. Our Boston mandate telemetry puts counter-offer incidence on that book at 27 percent and the median offer-to-acceptance window at 15 working days. Coverage is a separate measure: Sartori maps roughly 3,500 lawyers in Boston, inside a global program of about 1.5 million mapped profiles, thousands of mandate records and quarterly market surveys running since 2019.
Now the finding that does not flatter us. Of the six regulatory seats inside those nineteen closed searches, the 2 that ran past the seven-month end of our own stated band were both written as a single legal-and-regulatory scope — one requisition asking for European submission history, United States filing history and contract drafting in one person. We did not talk either client out of the combined brief at the start, and we should have. That specification is two searches sharing a headcount, and the market answers it with candidates credible on one half and coached on the other.
A second limit bounds everything above. 9 of the 68 in-house respondents in that cohort keep the regulatory calendar entirely with outside counsel and have no intention of moving it inside; those organizations never open a requisition, so they never enter our mandate telemetry at all. Our data sees the companies that decided to hire and is blind to the ones that decided not to. Within the same cohort, 41 of those 68 placed the calendar with regulatory affairs or quality rather than with legal, which is the structural reason the seat is invisible until it is urgent.
The search opens after the dateThe search opens before the date
- After the deficiency letter The business case writes itself and the seat is filled at a premium, under time pressure, from whoever is available rather than whoever is right.
- At the filing decision The commonest good outcome. Scope is written properly, but the calendar has already started and the first months are spent catching up to it.
- At the first process change A manufacturing site or supplier change is the earliest honest trigger. The seat is cheapest here and the argument for it is hardest to make, because nothing has gone wrong yet.
You are being asked to fund a seat whose value is a non-event. Write the calendar down first; the requisition then writes itself.
- Name the calendar first. Six dated items, each with an instrument and a document. A schedule is fundable in a way a job title is not.
- Split the scope. One requisition asking for submission history, filing history and contract drafting in one person is the specification that pushed two searches past seven months.
- Fix the reporting line. A counsel under regulatory affairs is priced as a manager; under the general counsel, as counsel who can say no to a submission.
- Budget the counter-offer. Incidence on the Boston in-house book is 27 percent and it lands late, once the current employer works out what the departing person was holding.
- Test on the joins. Ask what changes in five documents when a manufacturer moves a process. That separates the field faster than any credential.
The hire is not an audit of your function. It is the contract layer under a file you already own, and it is the layer that fails first.
- Keep the technical file. The dossier, the agency dialogue and the submission stay with regulatory affairs.
- Hand over the contract chain. Development and manufacturing agreements, data and materials rights, insurance verification and indemnity are legal instruments with regulatory deadlines attached.
- Use the insurance rule. The MHRA Phase 1 requirement effective 28 April 2026 is proof of cover, site verification and trial-file documentation: legal work with your deadline on it.
- Escalate the joins. Inconsistency between a label claim, a clinical overview and a comparability package is the failure mode, and it is nobody’s job until it is somebody’s.
- Say what the seat is not. A generalist head of legal cannot absorb this alongside commercial contracts, and saying so early is cheaper than saying it after a submission.
Two engagements, anonymized and typical of the book.
A Boston-area clinical-stage cell-therapy developer. The brief was a single head of legal covering commercial contracts, financing support and the European filing calendar, at a company with one product entering a registrational study. Ten weeks of market work produced a shortlist strong on commercial contracting and thin on submissions, and we told the chief executive the specification was the problem rather than the market. Rewritten as a regulatory counsel reporting to the general counsel, with commercial contracting left where it sat, it closed inside the four-to-seven-month band. The complication was internal: regulatory affairs had run the calendar for three years and read the new seat as a verdict on its work.
A European-headquartered contract development and manufacturing organization. The requirement was counsel for a Massachusetts site whose client contracts had gone silent on comparability obligations after a process change. The candidates who read best on paper came from pharmaceutical regulatory practice and had never negotiated a manufacturing agreement; the one who closed had done exactly that at a smaller manufacturer and took a title downgrade for the scope. A counter-offer landed on day eleven of the offer window and failed the way those usually fail: more money to keep doing a job the candidate had already decided was too narrow.
A chief legal officer at a listed gene-therapy company, interviewed inside the same cohort, described the sequence this article exists to interrupt: the seat was approved nine weeks after a regulator asked a question the company could not answer from its own files, The business case was unarguable from the moment the question arrived and unfundable for the eighteen months before it. Two things are worth watching over the next year: whether an advanced therapy medicinal product finally appears among the published Joint Clinical Assessment reports, which will set the template everyone drafts against, and whether the Massachusetts funding rebound of early 2026 turns into requisitions. The associate bands this seat competes against on the way in are set out in our Boston healthcare and life sciences associate salary read.
The business case was unarguable from the moment the question arrived and unfundable for the eighteen months before it.
Common questions about hiring advanced-therapy regulatory counsel
Who owns the regulatory calendar for a cell and gene therapy program in the clinic?
In most companies, no single named role: 41 of the 68 Boston in-house respondents in Sartori’s interview cohort placed the calendar with regulatory affairs rather than with legal. The work is unambiguous — a scoping submission, a CTIS record, a comparability package and the contractual rights over the data behind it. The owner is not. The calendar is assembled by regulatory affairs and defended by whoever signs the submission, which is why it fails at the joins rather than at any single filing.
What changed on 12 January 2025 for advanced therapy medicinal products?
From 12 January 2025 the EU Joint Clinical Assessment applies to new cancer medicines and advanced therapy medicinal products, on the European Commission’s own implementation page. A developer filing a marketing-authorization application from that date sends the summary of product characteristics and the clinical overview to the assessment secretariat, which opens scoping. The clinical evidence is then assessed once, centrally, instead of twenty-seven times. National bodies still decide price. The evidence package now has to satisfy a regulator and a payer assessment on overlapping timetables rather than sequential ones.
Is this a legal seat or a regulatory affairs seat?
Both: the two Sartori Boston in-house searches that ran past seven months in three years were the two written as a single legal-and-regulatory scope. The functions are not interchangeable. Regulatory affairs owns the submission, the agency dialogue and the dossier. Legal owns the contract chain that makes the dossier defensible: the development and manufacturing agreements, the data and materials rights, the insurance and indemnity positions, the disclosure that follows a safety signal. A company writing one requisition for both buys two roles on one headcount.
What does the seat pay?
No published band exists for this seat; the one dated public anchor is $2,041,511 in FY2025 total compensation, disclosed in a listed gene-therapy company’s 2026 proxy. That figure, from REGENXBIO’s DEF 14A filed 14 April 2026, covers an EVP whose title fuses Chief Strategy and Legal Officer, against $2,737,813 for the same seat in FY2024. It is one company’s disclosure, not a market average. Below officer level the package is anchored on the general in-house benchmark and then moved by the reporting line.
Why does this search take four to seven months?
Because the requisition usually asks for one person with both an EU submission history and a US filing history; Sartori’s Boston in-house book runs a 27 percent counter-offer incidence. Scarcity here is not seniority. The pool is assembled from two separate pipelines — regulatory lawyers who have never carried a comparability file, and regulatory-affairs professionals who have never negotiated a manufacturing agreement — and neither produces the combined profile at volume. The median offer-to-acceptance window on that book is 15 working days, so the delay sits in the search, not the close.
Should a Boston company hire this seat in-house or keep it with outside counsel?
Hire when the filing calendar becomes recurring: 9 of the 68 Boston in-house respondents keep it entirely with outside counsel and never open a requisition at all. The test is not company size. It is whether the calendar repeats. A single marketing-authorization application is a project and a panel handles it well. Two products in the clinic, a manufacturer changing a process, a UK Phase 1 site and an EU payer dossier is a standing obligation, and standing obligations are cheaper inside.
The Commission pages, the agency guidance, the proxy statements and the trade association behind every figure above.
Regulatory dates come from the European Commission, the European Medicines Agency, the Clinical Trials Information System guidance and the MHRA as reported by the Cell and Gene Therapy Catapult. Compensation and capital figures come from SEC filings. Massachusetts employment and funding figures come from MassBio. Credential requirements come from RAPS and the Solicitors Regulation Authority.
Sources & further reading
31 references- Sartori & Partners — Boston Legal Talent Research Programme (250 structured interviews; ~3,500 lawyers mapped; quarterly surveys since 2019; mandate telemetry) sartoriglobal.com ↗
- European Commission — Joint Clinical Assessments (application from 12 January 2025) health.ec.europa.eu ↗
- European Commission — Implementation of the Regulation on health technology assessment health.ec.europa.eu ↗
- European Commission — Health technology assessment key documents health.ec.europa.eu ↗
- European Medicines Agency — Clinical Trials Regulation ema.europa.eu ↗
- Clinical Trials Information System — Guidance and Q&As euclinicaltrials.eu ↗
- European Medicines Agency — Advanced therapy medicinal products: overview ema.europa.eu ↗
- EFPIA — Statement welcoming the first Joint Clinical Assessment report (9 June 2026) efpia.eu ↗
- European Commission — Critical Medicines Act (proposed March 2025) health.ec.europa.eu ↗
- FDA — Approved Cellular and Gene Therapy Products (current as of 18 August 2026) fda.gov ↗
- FDA — KRESLADI (marnetegragene autotemcel), approved 26 March 2026 fda.gov ↗
- Cell and Gene Therapy Catapult — Regulatory Round-up, November 2025 (published 3 December 2025) ct.catapult.org.uk ↗
- GOV.UK — Life Sciences Sector Plan (16 July 2025) gov.uk ↗
- SEC EDGAR — REGENXBIO Inc. DEF 14A, filed 14 April 2026 sec.gov ↗
- SEC EDGAR — REGENXBIO Inc. DEF 14A, filed 8 April 2025 sec.gov ↗
- SEC EDGAR — uniQure N.V. Form 8-K Exhibit 99.1, filed 8 January 2025 sec.gov ↗
- SEC EDGAR — bluebird bio, Inc. Form 10-K filing index, filed 27 March 2025 sec.gov ↗
- MassBio — 2026 Industry Snapshot massbio.org ↗
- RAPS — Regulatory Affairs Certification (RAC) raps.org ↗
- Solicitors Regulation Authority — Solicitors Qualifying Examination (SQE) sra.org.uk ↗
- Bristol Myers Squibb — Leadership team bms.com ↗
- CRISPR Therapeutics — Leadership crisprtx.com ↗
- Roche — Leadership roche.com ↗
- Covington & Burling — Food, Drug, and Device practice cov.com ↗
- Sidley Austin — Life Sciences practice sidley.com ↗
- Elevidys — encyclopedic chronology of the July 2025 clinical hold and CHMP opinion en.wikipedia.org ↗
- Sarepta Therapeutics — encyclopedic corporate chronology en.wikipedia.org ↗
- bluebird bio — encyclopedic corporate chronology en.wikipedia.org ↗
- Sartori & Partners — Is Life Sciences Law Hiring in 2026? ↗
- Sartori & Partners — In-House Counsel Salary 2026 ↗
- Sartori & Partners — Healthcare and Life Sciences Associate Salary, Boston ↗
The Joint Clinical Assessment report count is a snapshot taken on 3 September 2026 from a filtered listing, not an annual rate. The FDA product total is a cumulative stock as of 18 August 2026. The REGENXBIO figures are total compensation for one named officer seat in two consecutive fiscal years, not a market band. The uniQure figure is gross proceeds at pricing, not net. MassBio employment and funding figures cover different periods, 2025 and the first half of 2026 respectively. Leadership titles are as published by the companies themselves on the dates checked. Corporate chronologies for Elevidys, Sarepta Therapeutics and bluebird bio are encyclopedic sources, used for dated events that are corroborated by the regulatory actions they describe.
Sartori figures on this page come from the research program named in the first entry above: a Boston interview cohort, mandate telemetry over the trailing three years, and quarterly market surveys running since 2019. For the whole-specialism view of life sciences hiring, see is life sciences law hiring in 2026, and for the sector context around it the biotechnology and pharmaceuticals practice pages.
Next steps on the life sciences talent map.
This page owns one sub-niche: the advanced-therapy regulatory seat and the calendar it carries. These three cover the specialism, the benchmark and the bands around it.
Is Life Sciences Law Hiring in 2026?
The whole-specialism read: the two demand engines behind life sciences legal hiring, and the supply that answers them.
Read the specialism viewIn-House Counsel Salary 2026
The general in-house benchmark this seat is anchored on before the reporting line moves it.
See the in-house benchmarkHealthcare & Life Sciences Associate Salary, Boston
The Boston associate bands for the healthcare and life sciences practice, and what a move in-house costs against them.
Open the Boston bandsA quiet conversation
Opening this seat, or working out whether you need it yet?
We map regulatory and in-house legal talent across the advanced-therapy market, and we are just as willing to tell you the calendar does not justify a hire yet as to open a search. Confidential, no obligation.