**Remote Role**
Job opportunity with a top biopharmaceutical company that is looking for a Regulatory Affairs Manager to join its team on a 12-month contract with a possibility for conversion or extension!
Qualifications:
- Bachelor's degree in biology, chemistry, or a related science field
- Minimum of 5 years experience in the pharmaceutical or related industry
- Regulatory and drug development experience is required
Job Description/Skills:
- Coordinates and prepares document packages for regulatory submissions in alignment and compliance with local and regional registration requirements as well as with company policies
- Interacts effectively with functional departments in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicates and coordinates regulatory activities with other departments, as needed
- Monitors and collects assigned deliverables required for regulatory submissions
- Compiles all materials in an orderly fashion to facilitate timely submission to the FDA
- Review submission materials for errors or other content issues prior to submission.
- Maintains regulatory files (including submissions and correspondence) for Investigational New Drugs (INDs), Clinical Trial Authorizations (CTAs), and other regulatory applications
- Completes regulatory forms at the direction of Regulatory management
- Assists in the preparation of Annual Reports, Development Safety Update Reports (DSURs), Investigator's Brochures, and other documents required to maintain ongoing INDs, CTAs and other applications in good regulatory standing
- Reviews change controls for regulatory approval
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
