Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Associate Director – Global CMC Regulatory Strategy

Location: Uxbridge, Ontario – on site 3 days a week, remote 2 days a week.

Responsibilities

• Lead development & execution of global CMC regulatory strategies for hematology and oncology portfolios.
• Guide regulatory activities across development stages and mentor CMC RA staff.
• Represent CMC RA at program meetings and provide regulatory interpretation, positioning, and coverage of clinical development, market applications, and approval/post‑approval activities.
• Identify program issues and develop risk mitigation strategies, alternatives, and consensus.
• Review & provide strategic input on regulatory filing documents (INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements).
• Lead interactions with global regulatory authorities, including meetings, IR responses, and inspections.
• Perform final review/approval of compliance activities and confirm regulatory impact for clinical and commercial filings.
• Mentor colleagues on compliance assessment, guide process improvements, and lead training on SOPs and templates.
• Identify gaps in IOPS and global RA processes, propose improvements, and manage knowledge base of regulatory requirements.
• Initiate operational changes, policy modifications, 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 preferred.
• Proven track record supporting biological products through development and approval.
• Strong understanding of current worldwide CMC regulations and guidelines.
• Experience interacting with US FDA and other regulatory authorities.
• Experience with device regulatory requirements and combination product development processes is a plus.

Benefits and EEO Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, sexual orientation, gender identity or expression, marital status, civil partnership, citizenship, disability, or other protected characteristics. Reasonable accommodations will be provided to applicants with known disabilities or chronic illnesses within the recruitment process, unless it would impose undue hardship.

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