Temporary - Associate Manager, Regulatory Project Management

Regeneron Pharmaceuticals • Warren, MI

1d • Onsite

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, and may serve as the Regulatory Project Management lead for an assigned therapeutic area. The position helps ensure the success of regulatory programs in that area and works with Regulatory Affairs and cross-functional teams to coordinate regulatory activities and milestones.

The role is based in Tarrytown, Warren, or Cambridge and requires working on site three to four days per week. The position contributes to a science-driven organization developing medicines for people with serious diseases.

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.
• eCTD knowledge.
• 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 coordinate regulatory activities and milestones as the key contact.
• Guide team members and cross-functional groups in resolving issues involving timelines, submission documents, or other regulatory matters that could affect submission timeliness or quality.
• May oversee therapeutic areas by guiding team members who project-manage regulatory milestones, including pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs, Type II variations, and BLA annual reports.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Career Level: Mid Level