Job Summary
The Senior Manager will be responsible for overseeing the planning, writing, and implementation of global Chemistry, Manufacturing, and Controls (CMC) regulatory submissions specifically for biologic programs. This role is crucial in providing strategic direction and collaborating with various teams to ensure adherence to regulations and expedite submission processes.
Responsibilities
- Lead the development and execution of global CMC regulatory submissions for biologics.
- Provide strategic guidance to ensure compliance with regulatory standards.
- Collaborate with cross-functional teams to accelerate submission timelines.
- Stay informed on global regulatory standards related to biologics to support submission accuracy.
Qualifications
- Advanced degree or bachelor’s degree in a relevant scientific discipline.
- Around 8 years of experience in CMC regulatory affairs.
- In-depth knowledge of global regulatory requirements for biologics.
- Experience with eCTD and Module 3 documentation is essential.
