Associate Manager I - Reg CMC Strategy, NP CMC Support

About the role

Individual Contributor – responsible for own work (requiring periodic review) under general supervision:

What you'll do

• Develops renewal regulatory strategies while considering registered content, in collaboration with GRS‑CMC and Group Lead
• Prepares CMC contributions for renewal applications for assigned products across global markets; authors and/or compiles renewal documentation (e.g., Module 1
• Coordinates Module 1 and Module 3.2.R ancillary documents, as needed
• Reviews technical and supporting information for submission to support renewal applications
• Develops technical justifications for changes for agency submissions, as required

What you need

• 4–6 yrs of experience
• Regulatory affairs
• SOP writing
• PhD