A well-established biotechnology research organization in the Greater Boston area is looking to add a Senior Manager to their Regulatory Operations function working on their portfolio of biologic and cell therapy products.
The Senior Manager will be responsible for:
- Performing tasks as a key member of the Regulatory Operations function, working both with internal team members and external consultants/vendors
- Leading full life-cycle of Regulatory submissions for both products in post-approval and development stages
- Being an integral cross-functional team member and representative of the Regulatory Operations function
- Managing Regulatory systems (Veeva RIM, etc.)
The Senior Manager should have:
- 5-7 years of Regulatory Operations experience in the pharmaceutical industry
- A background of hands-on work with full life-cycle submissions, preferably with biologic products
- Extensive experience with Regulatory systems related to FDA submissions
If you are interested in learning more, please apply here.