Position Overview
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 Uxbridge based role requires on‑site presence 3 days per week and remote work 2 days per week. Remote work is not feasible. Relocation benefits may be offered if eligible.
Responsibilities
* 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, positioning, and support across clinical development, initial market applications, and approval/post‑approval activities.
* Identify program issues and develop appropriate regulatory strategies to mitigate filing risks, independently find alternative solutions/work‑arounds, and obtain consensus.
* Critically review and provide meaningful and strategic input on regulatory filing documents (INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSURs, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
* Lead and facilitate interactions with global regulatory authorities, including meetings, IR responses, and inspections.
* Perform final review and approve compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial filings in accordance with country‑specific guidance.
* Mentor colleagues in challenging compliance assessment discussions with SMEs or senior management; identify opportunities for process improvement.
* Develop working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
* Identify gaps in the IOPS and global RA processes, report them to higher management, and help to improve business efficiency.
* Support the establishment, management, and maintenance of 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.
Qualifications
• Bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience.
• Advanced degree is preferred.
• Proven track record supporting biological products through development and approval is a distinct advantage.
• Strong understanding of current CMC worldwide regulations and guidelines.
• Experience interacting with the US FDA and other regulatory authorities.
• Experience with device regulatory requirements and development processes for combination products is a plus.
Benefits
Regeneron offers a competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits. Additional information about benefits is available during the recruitment process.
Equal Employment Opportunity
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.
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