New · posted Nov 11
UniQure Biopharma B.V. · Biotechnology
Executive Director, Regulatory CMC & Devices
- Lexington, MA
- Hybrid
- Full-time
- Director
The role
Place in the Organization
At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.
The Executive Director, Regulatory Affairs CMC & Device will provide strategic leadership for global regulatory CMC and device activities across the company’s rare disease portfolio. The Executive Director will provide integrated CMC and device regulatory strategies and its translation into operational goals across the product lifecycle, from early clinical development through post-approval lifecycle management. As a core member of the CMC Regulatory Affairs team, the Executive Director provides functional leadership within CMC Regulatory and to cross-functional teams.
This position requires deep regulatory expertise in the CMC aspects of gene-therapy drug development, strong people-leadership capabilities, and the ability to effectively collaborate in a highly matrixed environment, partnering closely with senior leaders in Technical Operations, Analytical-, Product-Development, and Quality.
What you need
Key result areas (major duties, accountabilities and responsibilities)
- Strategic & Operational Leadership: Set the vision and strategic direction for regulatory CMC activities supporting gene-therapy development, translating corporate goals into robust global regulatory strategies and operational goals, and oversee their execution for the assigned portfolio of products, from early development through post-marketing.
- Combination Product & Device Execution: Lead the formulation and implementation of regulatory strategies for combination products and device/biologics interfaces; collaborate closely with Therapeutic Regulatory Leads to align CMC, device, and clinical development strategies to achieve corporate objectives.
- Functional & Resource Management: Contribute to the development of the global CMC Regulatory team.
- Strategy Delivery: Provide CMC and Device regulatory strategy input to the product specific Global Regulatory Strategy and Plan (GRSP) including assessment of regulatory risk, probability of regulatory success, and mitigation strategies to support informed decision‑making by senior leadership.
- Health Authority Interactions: Provide strategic leadership for CMC Health Authority engagements (including FDA/CBER/CDRH, EMA, MHRA); serve as the senior functional lead for major regulatory interactions (e.g., pre-IND, End-of-Phase, scientific advice, pre-BLA/MAA, pre-Subs) in partnership with Therapeutic Leads.
- Submission Strategy & Oversight: Provide strategic oversight of the quality, technical review, and timely submission of high-quality CMC and device regulatory documentation, including INDs/CTAs, scientific advice packages, BLAs/MAAs, and responses to agency queries.
- Partner closely within the global regulatory affairs team and with relevant cross-functional teams to ensure alignment of regulatory CMC strategies.
Provide strategic direction and seek alignment with relevant cross-functional stakeholders regarding the implementation of phase appropriate CMC and device regulatory requirements to the manufacture and control of uniQure products. - Regulatory Intelligence & Application: Monitor evolving regulatory guidelines, precedents, and industry trends regarding cell/gene therapies and devices, rapidly translating this intelligence into strategic and operational adjustments to maintain a competitive advantage.
- Process Excellence & Compliance: Be accountable for compliance with global regulatory requirements, while continuously driving the optimization of internal CMC regulatory policies, workflows, systems, and standard operating procedures (SOPs), in line with evolving industry best practices.
- Governance: Represent Regulatory CMC and Device in cross functional committees and senior governance forums.
Qualifications & Skills
- Bachelor’s degree in a relevant scientific or engineering discipline; advanced scientific degree (MS, PharmD or PhD) strongly preferred.
- 15+ years of progressive Regulatory Affairs experience within the pharmaceutical and/or biotechnology industry (gene therapy and biologics).
- Leadership experience: Successful experience in leading a diverse community of professionals in a global and matrix environment is required, including workforce and budget planning. (Seasoned leader, decision maker and constructive challenger)
- Experience with the unique CMC and device regulatory aspects of gene and/or cell therapy products is highly desirable.
- Demonstrated success leading global CMC and device combination product regulatory strategies for multiple development programs across clinical stages (Phase 1–4), including experience with global registrations.
- Post marketing experience including management of CMC regulatory activities supporting marketed products, lifecycle management, variations and regulatory commitments.
- Proven experience interacting with global Health Authorities (e.g., FDA, EMA) at a strategic level.
- RAPS Regulatory Affairs Certification (RAC-Drugs and/or RAC-Devices), a plus
- Demonstrated experience leading the build and development of regulatory CMC teams in a matrixed, cross‑functional environment.
- Demonstrated deep knowledge of global regulatory requirements governing Advanced Therapy Medicinal Products.
- Demonstrated strong strategic thinking, risk assessment, and decision‑making capabilities.
- Ability to influence and collaborate effectively with senior leadership and cross‑functional stakeholders.
- Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues to senior leadership.
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
US Salary Range
$275,000—$332,000 USD
uniQure posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure’s Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via [email protected].
Pay
$275,000 – $332,000 a year
Employer providedWhere you'll work
Lexington, MAHybridOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesUniQure Biopharma B.V.'s statements, word for word
uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [email protected].
uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information — including disclosures for California residents under the CCPA and for applicants under the GDPR — please review our applicant privacy notice.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 45% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts15 roles publishing pay
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $275,000 | — | $332,000 |
| Massachusetts (middle half) | $193,250 | $210,000 | $252,500 |
| All US (middle half) | $191,250 | $209,500 | $241,000 |
This role: UniQure Biopharma B.V.'s own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 89 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not uniQure's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Regulatory submissions4
- Documentation and SOPs2
- Clinical trial conduct2
- GMP and compliance1
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory CMC work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA markingNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q11(official source, opens in a new tab)Development and manufacture of drug substances
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ICHICH M7(official source, opens in a new tab)Assessment and control of mutagenic impurities
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
uniQure on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 50%
- Quality2 33%
- Clinical1 17%
By level
- Director4 67%
- VP & Executive2 33%
More roles at uniQure
- View role
Medical Director, Clinical Trial Lead
Remote, USDirectorBiotechnology$205K
- View role
Associate Director, Quality Control
Lexington, MA · HybridDirectorBiotechnology$188K
- View role
Vice President, Regulatory Strategy
Lexington, MA · HybridVP & ExecutiveBiotechnology$309K
- View role
Director, Corporate Quality
Lexington, MA · HybridDirectorBiotechnology$205K
Similar Regulatory CMC roles elsewhere
- View role
Associate Director, Regulatory CMC, Biologics
Vertex PharmaceuticalsBoston, MA · HybridDirectorBiotechnology$166K–$250K
- View role
Associate Director, Analytical Development & Quality Control
Entrada TherapeuticsRemote, US) / Boston, MADirectorBiotechnology$172K–$202K
- View role
Executive Director, Regulatory Affairs CMC
Crescent BiopharmaWaltham, MADirectorBiotechnology$290K–$323K
- View role
Associate Director, Regulatory Affairs, CMC- Biologics
Alnylam PharmaceuticalsCambridge, MA +1 more · HybridDirectorBiotechnology$171K
Executive Director, Regulatory CMC & Devices at uniQure
Open until filled. $275K–$332K a year, employer provided.