Director CMC Regulatory Affairs

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, CMC Regulatory Affairs to lead our Haematology/Oncology CMC & Combination Products team, supporting our global biologics and device portfolio. In this role, you will set and drive global regulatory strategy across the product lifecycle — from initial clinical registrations through market approvals and post-approval management — while collaborating with regulatory staff, development partners, project teams, and health authorities worldwide.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
•    Location: Dublin
•    Work model: 3 days/week onsite

Discover your role:
•    Set the global regulatory strategy and operational direction for a biologics and combination products portfolio
•    Lead the preparation and submission of key regulatory documents, from briefing books to BLAs and MAAs
•    Guide interactions with global health authorities, including meetings, inquiries, and inspections
•    Advise on compliance activities, weighing regulatory impact across clinical and commercial filings
•    Shape department strategy, objectives, and work plans that keep the team focused on what matters most
•    Coach team members through complex, first-of-their-kind program challenges
•    Partner across functions to strengthen practices and build new processes
•    Develop and grow regulatory talent, building bench strength for the future

This role requires:
•    Bachelor's degree with 10+ years of pharmaceutical/biotech industry experience, including 8+ years of relevant CMC experience — or a Master's with 8+ years, or a PhD with 3+ years
•    3+ years of applicable managerial experience
•    Strong understanding of current worldwide CMC/CP regulations
•    Experience leading CMC/CP sections of marketing authorisations, CTAs/INDs, and post-approval submissions
•    Direct experience engaging with the FDA and other regulatory authorities
•    Track record supporting biological products and combination products through development and approval is preferred
•    Experience with device regulatory requirements and development processes for combination products is preferred
•    Human Factors experience is preferred
 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)