Regulatory Project Manager
Full Time
Director Level
3+ years
Posted 1 month ago Expired
This job has expired
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Upload Your ResumeAbout This Role
This role involves leading the planning and execution of regulatory projects, managing timelines and risks, and driving cross-functional alignment. The Regulatory Project Manager will also track deliverables and proactively resolve roadblocks to ensure compliance with FDA/EMA/ICH expectations.
Responsibilities
- Lead planning and execution of regulatory projects (IND/BLA/NDA submissions, amendments, FDA responses, lifecycle activities)
- Build and manage timelines, risks, and communication pathways
- Drive cross-functional alignment with Regulatory, Quality, Clinical, CMC, and external partners
- Track deliverables and proactively resolve roadblocks
- Support preparation and QC of regulatory documents to ensure accuracy and compliance with FDA/EMA/ICH expectations
- Strengthen processes, templates, and workflows across the regulatory function
Requirements
- 3–7 years in Regulatory Affairs, Regulatory Ops, or project management within pharma/biotech/FDA
- Strong understanding of FDA regulatory requirements
- Excellent communication, organization, and stakeholder-management skills
- Proactive, solutions-oriented mindset
- Understanding of eCTD software
Qualifications
- 3-7 years in Regulatory Affairs, Regulatory Ops, or project management within pharma/biotech/FDA
Skills
Communication
*
Organization
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Stakeholder Management
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eCTD software
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* Required skills