What are the responsibilities and job description for the Manager, Global Regulatory Sciences (Drug Development) - Cambridge, MA (Hybrid Role) position at The Fountain Group?
We are currently seeking a Manager, Global Regulatory Sciences (Drug Development) for a prominent Pharmaceutical client of ours. This position is in Cambridge, MA (Hybrid Role). Details for the position are as follows:
Job Description:
Job Description:
- Pay: 65.00-75.00/hr., depending on experience.
- Temp to permanent role.
- Hybrid role. Cannot be fully remote.
- Manager is open to candidates open to relocate at their own expense.
- We’re looking for a candidate to take on a tactical program oversight role within a high-visibility drug development program. This person will support the program lead, who is focused on strategic execution.
- Must have a strong background in drug development.
- Responsible for driving document development for regulatory submissions, managing timelines, and representing the program cross-functionally.
- Roughly 60-75% of the role involves hands-on work developing, reviewing, and tracking documentation for regulatory submissions. The remaining 25-40% will be spent in tactical, cross-functional meetings with groups like Clinical Science and CMC (Manufacturing).
- Must be able to facilitate timelines, coordinate input from stakeholders, and stay organized under pressure.
- Oncology/ mast cell disease / rare diseases drug development is a plus but not required.