Associate Director, CMC Regulatory Affairs; Hematology​/Oncology

Build Our Future Together

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs staff, support cross‑functional and external partners, and serve as a key liaison in regulatory authority interactions.

This is a Uxbridge based position requiring the employee to be on‑site three days per week and to work from home two days. A fully remote role is not possible. Relocation benefits may be offered for eligible candidates.

• Lead product development activities from a CMC regulatory standpoint with input from senior management.
• Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and coverage for clinical development, initial market applications, and approval/post‑approval activities.
• Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work‑arounds, and obtain consensus.
• Critically review and provide meaningful strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
• Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
• Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country‑specific guidelines.
• Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; identify opportunities for process improvement.
• Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
• Identify gaps in IOPS and global RA processes, report to higher management, and contribute to business efficiency improvements.
• Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
• Find opportunities to initiate operational changes and policy modifications.
• Manage and coach team members.

• Bachelor’s degree and a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred.
• Proven track record supporting biological products through development and approval.
• Good understanding of current CMC worldwide regulations and guidelines.
• Experience interacting with the U.S. FDA and other regulatory authorities.
• Experience with device regulatory requirements and combination product development processes is a plus.

Regeneron offers a competitive and comprehensive total rewards package, including annual bonuses or incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, disability), paid time off, and family support benefits. Details vary by country and role.

Regeneron is an equal‑opportunity employer. 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.

Reasonable accommodations will be provided for applicants with disabilities or chronic illnesses within the extent permissible by law.