Associate II - Regulatory CMC Strategy @ Pfizer

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities include the following, but not limited to:

• Ensures effective coordination and collaboration with GRS-CMCs and the regional regulatory leads to ensure key submission deliverables for the assigned projects to the team.
• Responsible for end to end CMC contribution for the assigned projects; Reviews the assigned regulatory activities including the related technical/supportive information/ documents for completeness and accuracy; Responsible for development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC; Responsible for authoring and/or compiling Regulatory Strategy Documents (RSD) where needed; Responsible for authoring of CMC content in Module 1, Module 2. 3, M3. 2. S/P/R as agreed upon with the GRS CMC within agreed timelines.
• Responsible for identification and communication of identified risks to the GRS CMCs and/or appropriate leadership, also proposes mitigation strategy with the support of team lead; Ensures resolution of issues and manages regulatory risks within project.
• Reviews and applies pertinent global regulatory guidelines. Exhibits technical / functional expertise and provides strategies on regulatory requirement, negotiates with and influences the cross functional teams, colleagues and external partners to ensure regulatory data requirements are met.
• Coordinates with the respective team for M3. 2. R Ancillary documents
• Represents HBU GRA CMC point of view and meets with key stakeholders to resolve challenges.
• Coordinates internal document review and sign off.
• Utilizes Pfizer s CMC systems, i. e. GDMS, PDM, SPA, etc, as appropriate.
• Supports Query and/or commitment management in collaboration with GRS CMCs.
• Maintains conformance systems maintenance in support of the GRS CMCs