Regulatory Project Management Lead (Onsite)

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 110,000 - 135,000; Full time

Job summary

Regeneron is seeking a Temporary Associate Manager for Regulatory Project Management to lead strategic planning and execution of regulatory milestones from IPA to post-marketing. You will coordinate cross-functional teams, chair regulatory sub-teams, and monitor major submissions to ensure timely delivery across indicated therapeutic areas.

The role supports a fast-growing, science-driven organization and offers on-site collaboration with regulatory leadership to advance patient-focused

Qualifications

• Bachelor’s degree required.
• 5+ years of industry and/or relevant experience.
• Strong knowledge of regulatory agency regulations, guidelines, and specifications (FDA, EMA, ICH).
• eCTD knowledge required.
• MS Project skills required.
• MS Office and Adobe Acrobat proficiency; SharePoint desirable.

Responsibilities

• Partners with Regulatory Affairs to drive program milestones.
• Facilitates Global Regulatory Sub-team meetings with liaison as chair.
• Tracks progress of major submissions and creates timelines.

Skills

Regulatory knowledge

Project management

MS Office

SharePoint

eCTD knowledge

Education

Bachelor’s Degree

Tools

MS Project

Adobe Acrobat

Job description

Regeneron is seeking a Temporary Associate Manager for Regulatory Project Management to lead strategic planning and execution of regulatory milestones from IPA to post-marketing. You will coordinate cross-functional teams, chair regulatory sub-teams, and monitor major submissions to ensure timely delivery across indicated therapeutic areas.

The role supports a fast-growing, science-driven organization and offers on-site collaboration with regulatory leadership to advance patient-focused