Contract Regulatory Specialist - 100% Remote
One Year Contract
My client in the pharmaceutical industry is looking for a fully remote Regulatory Specialist. This international company is pioneering new techniques for treating mental health disorders and looking to expand its team after multiple years of growth.
The Regulatory Specialist will be responsible for:
- Preparing and managing the Regulatory submissions including but not limited to supplements and amendments
- Correspondence with the FDA, drafting cover letters, and response documents
- Holding kickoff meetings, coordinating section updates and review
- Maintaining compliance with FDA, support Promotional Review Committee, and Risk Mitigation Strategy
- Creating Regulatory Objectives
The Regulatory Specialist should have the following qualifications:
- Bachelor's Degree or Higher in a related field
- A minimum of 3 years of Regulatory Experience
- Experience using document management systems
- Strong problem-solving and time management skills
If you are interested in the Regulatory Specialist role, then please don't wait to apply!