Pfizer Regulatory Affairs job vacancy at India – Chennai

Associate Manager I – Reg CMC Strategy, Brands CMC

Discover an opportunity with Pfizer Healthcare, Global Regulatory Sciences to pursue your dreams. Join us for a Walk-in interview with Pfizer Business Leaders at Svenska Design Hotels, Bangalore on 17th & 18th of February 2024. Time: 9:00 am to 5:00 pm (IST)

Venue:

Svenska Design Hotels 56-D, Electronic City, Bangalore 560 100, India

Inviting applications from both experienced & aspiring RA professionals with competency in authoring & review of high quality CMC dossier content for New Registrations & Post-Approval Variations/ License Maintenance for Global markets.

Roles:

Multiple roles (Associate to Principal Manager) with-in Global Regulatory Sciences

• Responsible for managing assigned regulatory projects/ CMC programs of various 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).
• 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; 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.

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