Senior Manager Regulatory Strategy
About this role
About the Role
The Senior Manager, Regulatory Strategy supports the creation and implementation of US regulatory strategies to enable successful development and approval of assigned drug or biologic products. They participate on global cross-functional teams to ensure US requirements are addressed in a compliant and efficient manner, and serve as a regulatory partner throughout the product lifecycle.
What You'll Do
- Provide regulatory review of product documentation intended for FDA submissions for accuracy and compliance with FDA regulations.
- Manage, review, and represent US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings.
- Identify regulatory risk, problem-solve, and offer solutions.
- Manage/support related FDA submission activities in compliance with current regulations and guidances.
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