Regulatory Operations Manager
Job Summary
To enhance regulatory efficiency, the full-time Regulatory Operations Manager will coordinate high-quality regulatory publishing deliverables, ensure timely submissions, and drive innovative process changes while working remotely.
Key responsibilities
- Manage regulatory publishing and submission assignments, ensuring quality and timeliness
- Act as the primary liaison for regulatory publishing activities across R&D functions
- Design and implement processes to maximize electronic submission lifecycle and compliance
Required qualifications
- Minimum of 5 years of regulatory operations experience with electronic submissions
- In-depth knowledge of FDA/EMA/HC/Swiss Medic regulations for submissions
- Expertise in eCTD formatting, publishing, and archiving
- Strong experience with Document Management Systems and publishing tools
- Recent experience with NDAs / MAAs is essential
Complete Job Description
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