Regulatory Operations Consultant
We are in search of a Regulatory Affairs Consultant for a client who is implementing a major EDMS overhaul. You will be responsible for leading the preparation; review and submission of regulatory documents, ensuring submissions comply with applicable health authority and company requirements. You will provide operations support for all regulatory submissions including electronic and paper submissions.
Main Responsibilities:
- Ensure timely delivery of high-quality regulatory submissions following established U.S. and international regulations as well as company and internal processes
- Develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions
- Prepare regulatory documents for submission to Health Authorities in accordance with current regulations and guidance
- Maintain submission archives for all products and will be responsible for archiving of submissions and all regulatory correspondence
Knowledge and Skills:
- Minimum BS required
- Minimum of 3-5 years Regulatory Affairs experience required
- Must have ECTD experience
- Knowledgeable in ICH and FDA guidelines relevant to regulatory submissions a plus
- Ability to complete large complex projects on time
- Good communication skills (verbal and written)
- Strong ability to work independently and in a team environment
Number of hours worked per week: 40 hours
Length of Assignment: 9 months
Position Location: Cambridge, MA