Regulatory Project Lead: IND to Post‑Marketing

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 115,000 - 155,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Temporary Associate Manager for Regulatory Project Management to lead strategic planning and execution of regulatory milestones from IND Project Approval to post-marketing. The role may serve as the Reg PM lead for a therapeutic area, coordinating with cross-functional teams to ensure timely, compliant submissions.

Work location options include Tarrytown, Armonk, Warren, or Cambridge with 3-4 days on site.

Qualifications

• Bachelor’s Degree required.
• 5+ years of industry and/or relevant experience.
• Strong knowledge of applicable Regulatory Agency regulations (FDA, EMA, ICH).
• Requires eCTD knowledge.
• Proficiency with Microsoft Project.
• Working knowledge of MS Office applications and Adobe Acrobat.
• SharePoint experience desirable.

Responsibilities

• Lead regulatory milestones from IND Project Approval to post-marketing.
• Coordinate cross-functional teams and regulatory sub-teams.
• Create submission timelines and responsibility matrices.
• Maintain accurate program timelines and cross-reporting.
• Communicate projections and progress to stakeholders; serve as main contact for regulatory activities.

Skills

Regulatory knowledge

Project coordination

Stakeholder communication

Leadership

Education

Bachelor’s Degree

Tools

Microsoft Project

SharePoint

Adobe Acrobat

MS Office

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Temporary Associate Manager for Regulatory Project Management to lead strategic planning and execution of regulatory milestones from IND Project Approval to post-marketing. The role may serve as the Reg PM lead for a therapeutic area, coordinating with cross-functional teams to ensure timely, compliant submissions.

Work location options include Tarrytown, Armonk, Warren, or Cambridge with 3-4 days on site.