Associate Director, Regulatory Submission Project Management
Regeneron
June 26, 2026
Remote friendly (Tarrytown, NY)
United States
Operations
Discover Your Role
- Provide senior leadership in strategic planning and execution of regulatory milestones from IND Project Approval (IPA) through post-marketing.
- Serve as Reg PM lead for assigned therapeutic area(s) (TA) and drive organizational excellence and consistency across regulatory programs.
- Provide strategic oversight across TAs; direct team members managing milestones including pre-IND/Scientific Advice, INDs, CTAs, BLAs, sBLAs, MAAs, Type II variations, and BLA annual reports (functional quality and consistency accountable).
- Partner with senior Regulatory Affairs leadership to meet regulatory milestones and influence strategy and prioritization.
- Lead/facilitate Global Regulatory Sub-team meetings; drive alignment and resolution of complex cross-functional issues.
- Conduct working group meetings to monitor/track major submission progress.
- Conduct kickoff meetings for major submissions (INDs, CTAs, BLAs, sBLAs, MAAs and variations).
- Review and own regulatory portfolio slides for accurate milestone dates; present to stakeholders and drive informed decisions.
- Create submission timelines and responsibility matrices; maintain cross-functional program timelines.
- Communicate program projections/progress; key contact for coordinating regulatory activities and milestones.
- Act as senior escalation point and strategic advisor; resolve complex timeline/document/regulatory issues and establish best practices/process improvements.
This Role Requires
- Minimum Bachelor’s Degree with 10+ years combined industry and relevant experience.
- Strong knowledge of applicable regulatory agency regulations/guidelines/specifications (e.g., FDA, EMA, ICH).
- eCTD knowledge.
- Microsoft Project skills required.
- Project management skills required; PMP (or equivalent) preferred.
- Working knowledge of MS Office applications and Adobe Acrobat required; SharePoint/electronic document management systems desirable.
Application instructions
- Apply now to take your first step towards living the Regeneron Way.
- Provide senior leadership in strategic planning and execution of regulatory milestones from IND Project Approval (IPA) through post-marketing.
- Serve as Reg PM lead for assigned therapeutic area(s) (TA) and drive organizational excellence and consistency across regulatory programs.
- Provide strategic oversight across TAs; direct team members managing milestones including pre-IND/Scientific Advice, INDs, CTAs, BLAs, sBLAs, MAAs, Type II variations, and BLA annual reports (functional quality and consistency accountable).
- Partner with senior Regulatory Affairs leadership to meet regulatory milestones and influence strategy and prioritization.
- Lead/facilitate Global Regulatory Sub-team meetings; drive alignment and resolution of complex cross-functional issues.
- Conduct working group meetings to monitor/track major submission progress.
- Conduct kickoff meetings for major submissions (INDs, CTAs, BLAs, sBLAs, MAAs and variations).
- Review and own regulatory portfolio slides for accurate milestone dates; present to stakeholders and drive informed decisions.
- Create submission timelines and responsibility matrices; maintain cross-functional program timelines.
- Communicate program projections/progress; key contact for coordinating regulatory activities and milestones.
- Act as senior escalation point and strategic advisor; resolve complex timeline/document/regulatory issues and establish best practices/process improvements.
This Role Requires
- Minimum Bachelor’s Degree with 10+ years combined industry and relevant experience.
- Strong knowledge of applicable regulatory agency regulations/guidelines/specifications (e.g., FDA, EMA, ICH).
- eCTD knowledge.
- Microsoft Project skills required.
- Project management skills required; PMP (or equivalent) preferred.
- Working knowledge of MS Office applications and Adobe Acrobat required; SharePoint/electronic document management systems desirable.
Application instructions
- Apply now to take your first step towards living the Regeneron Way.