Senior Manager/Manager Regulatory Operations
4 weeks ago
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.
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