Associate Manager I - Reg CMC Strategy, NP CMC Support
Core
Manages day-to-day CMC contributions for Annual Reports and License Renewal applications across global markets, preparing documentation and technical justifications in line with regulatory guidelines.
Role type
Associate Manager I, Regulatory CMC Strategy & Support
Builds
Annual Reports and License Renewal regulatory submissions for global markets
Domain
Pharmaceutical Regulatory Affairs (CMC)
Required skills
CMC strategy development, regulatory documentation authoring (Module 1, 2.3.S/P, 3.2.S/P/R/A), technical justification for agency submissions, query response management, internal document review coordination, Pfizer systems proficiency (PEARL, GDMS, PDM, SPA)
Preferred skills
Experience with biologics and biosimilars, knowledge of USFDA and EMA regulations, stability contribution management, post-approval change management
Technologies
PEARL, GDMS, PDM, SPA, Veeva
Responsibilities
Develops renewal regulatory strategies, prepares CMC contributions for renewal applications, authors and compiles renewal documentation, reviews technical and supporting information for submission, develops technical justifications for changes, supports query responses and commitment management, coordinates internal document review and sign-off activities, manages day-to-day regulatory activities for Annual Reports, reviews changes for completeness and accuracy, updates impacted dossier components, escalates identified risks to leadership
Seniority
Associate Manager I, individual contributor with periodic review