We are currently seeking a Senior Manager/Manager Regulatory Operations for a client in the Biotechnology sector. The role is located in the Greater Boston area on a weekly hybrid basis. As the Senior Manager Regulatory Operations, you will work closely with the Regulatory Affairs team and be responsible for managing the preparation, submission, and maintenance of regulatory filings.
Responsibilities
- Manage the preparation, submission, and maintenance of regulatory filings
- Ensure that all regulatory documents are of high quality and are compliant with relevant regulatory guidelines
- Work closely with the Regulatory Affairs team to develop and implement regulatory strategies
- Manage regulatory processes and systems (Veeva RIM)
- Provide guidance and support to cross-functional teams on regulatory operations matters
- Meet with Executive leaders within the organization on behalf of Regulatory Operations
- Participate in regulatory agency meetings and provide support as required
Requirements
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Strong project management skills
- Good understanding of FDA and other regulatory guidelines
- 5 to 7 years within Regulatory Operations
If you are interested in learning more about this position, please apply here.
