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.
• Perfo...