Temporary - Associate Manager, Regulatory Project Management

Regeneron Pharmaceuticals • Warren, MI

2d • Hybrid

About The Position

Regeneron is seeking a temporary Associate Manager to join its Regulatory Project Management team. The role leads strategic planning and execution of regulatory milestones from IND Project Approval (IPA) through post-marketing. The position may serve as the Regulatory Project Management lead for an assigned therapeutic area and help ensure the success of its regulatory programs. The role is based in Tarrytown, Warren, or Cambridge, with 3–4 days per week on site.

Requirements

• Bachelor’s degree.
• At least 5 years of industry and/or relevant experience.
• Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications, such as FDA, EMA, and ICH requirements.
• Knowledge of eCTD.
• Microsoft Project skills.
• Working knowledge of MS Office applications and Adobe Acrobat.

Nice To Haves

• Project management skills.
• Working knowledge of electronic document management systems such as SharePoint.

Responsibilities

• Partner with Regulatory Affairs to drive program teams toward successful completion of regulatory milestones.
• Facilitate Global Regulatory Sub-team meetings with a Regulatory Affairs liaison serving as meeting chair.
• Conduct working-group meetings to monitor and track progress of major submissions.
• Conduct kickoff meetings for major submissions, including INDs, CTAs, BLAs, sBLAs, MAAs, and variations.
• Review regulatory portfolio slides for complete and accurate milestone dates in preparation for cross-functional and upper-management discussions.
• Create submission timelines and responsibility matrices through cross-functional discussions.
• Maintain accurate program timelines for cross-reporting with other functional groups.
• Communicate program projections and progress, and serve as the key contact for coordinating regulatory activities and milestones.
• Guide team members and cross-functional groups in resolving issues related to timelines, submission documents, or other regulatory matters that could affect submission timeliness or quality.
• May provide therapeutic-area oversight by guiding team members who project-manage regulatory milestones, including pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports.

Benefits

• 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, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Career Level: Manager