Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron
2 hours ago
Remote friendly (Tarrytown, NY)
United States
Corporate Functions
Responsibilities:
- Lead development and execution of global CMC regulatory strategies for hematology and oncology portfolios.
- Guide regulatory activities across development stages.
- Mentor CMC Regulatory Affairs (RA) staff and manage/coaching team members.
- Represent CMC RA at program meetings and provide regulatory interpretation and strategy for clinical development, initial market applications, and approval/post-approval.
- Identify program issues and develop mitigation strategies for filing risks; find alternative solutions/work-arounds and obtain consensus.
- Critically review and provide strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to expedite development, licensure, and marketing of drugs/biologics.
- Lead/facilitate interactions with global regulatory authorities (meetings, IR responses, inspections).
- Perform final review/approval of portfolio compliance activities to confirm regulatory impact and submission requirements per country guidance.
- Develop working instructions, SOPs, and/or templates to standardize CMC RA practices.
- Identify gaps in IOPS/global RA processes and help improve business efficiency; maintain a knowledge base of emerging CMC regulatory requirements.
Qualifications:
- Bachelor’s degree with 10+ years pharmaceutical/biotech industry experience and 5+ years relevant CMC experience.
- Advanced degree preferred.
- Proven track record supporting small molecule drugs and/or biological products through development and approval (distinct advantage).
- Strong understanding of current CMC worldwide regulations and guidelines.
Required/Preferred Skills & Experience:
- Strong collaboration/teamwork across cross-functional teams.
- Proven ability to manage multiple priorities.
- Experience interacting with US FDA and other regulatory authorities.
- Experience with device regulatory requirements and combination products is a plus.
Application Instructions:
- Apply now.
- Lead development and execution of global CMC regulatory strategies for hematology and oncology portfolios.
- Guide regulatory activities across development stages.
- Mentor CMC Regulatory Affairs (RA) staff and manage/coaching team members.
- Represent CMC RA at program meetings and provide regulatory interpretation and strategy for clinical development, initial market applications, and approval/post-approval.
- Identify program issues and develop mitigation strategies for filing risks; find alternative solutions/work-arounds and obtain consensus.
- Critically review and provide strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to expedite development, licensure, and marketing of drugs/biologics.
- Lead/facilitate interactions with global regulatory authorities (meetings, IR responses, inspections).
- Perform final review/approval of portfolio compliance activities to confirm regulatory impact and submission requirements per country guidance.
- Develop working instructions, SOPs, and/or templates to standardize CMC RA practices.
- Identify gaps in IOPS/global RA processes and help improve business efficiency; maintain a knowledge base of emerging CMC regulatory requirements.
Qualifications:
- Bachelor’s degree with 10+ years pharmaceutical/biotech industry experience and 5+ years relevant CMC experience.
- Advanced degree preferred.
- Proven track record supporting small molecule drugs and/or biological products through development and approval (distinct advantage).
- Strong understanding of current CMC worldwide regulations and guidelines.
Required/Preferred Skills & Experience:
- Strong collaboration/teamwork across cross-functional teams.
- Proven ability to manage multiple priorities.
- Experience interacting with US FDA and other regulatory authorities.
- Experience with device regulatory requirements and combination products is a plus.
Application Instructions:
- Apply now.