Executive Director, Regulatory Affairs - Cell Medicine

In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for the Regeneron Cell Medicines, based in Cambridge, MA, a business unit for Regeneron Pharmaceuticals Inc to help advance the use of CAR T therapies in hematologic and solid tumors, autoimmunity, and novel conditioning / lymphodepletion options.

In this position you will provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a critical role overseeing the strategy, preparation, and submission of high‑quality INDs, CTAs, and original marketing applications (BLAs/MAAs) and interactions with health authorities.

Furthermore, this role leads broadly in cross-functional and multicultural environment and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders.

A typical day as an Executive Director might look like:

• Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and commercial products

• Develop and maintain health authority engagement strategy, interaction plan, and calendar, driving the formulation of briefing documents focused on strategic and scientific content.

• Develop and mentor the regulatory team and provide project teams with the strategic regulatory guidance to expedite product development, registration and through lifecycle management.

• Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for investigational and commercial products

• Directs and oversees the Regulatory CMC function in preparing high-quality CMC related regulatory submissions and supports the Regulatory CMC leads in interactions and response to regulatory health authorities to secure investigational applications, amendments, and marketing application clearance and/or approvals.

• Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA.

• Identifies the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs.

This role might be for you if:

• Experience in Cell & Gene Therapy and regulatory expedited development and approval pathways, preferred.
• Excellent oral and written communication and presentation skills
• Demonstrated experience supporting both development programs and marketed products
• Prior experience with IND & BLA submissions strongly preferred
• Prior experience managing regulatory staff and department budgets
• Pharm.D, M.D or Ph.D. in biochemistry, biology, pharmacy, or related pharmaceutical fields including biochemical engineering.
• Typically requires 15+ years of experience in pharmaceutical or biotech industry with a minimum of 10 years of progressively responsible experience in Regulatory Science CMC for biologics or 4 + years’ experience in Cell & Gene Therapy /ATMPs.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)