Associate I – Reg CMC Strategy

Jobtailor; Chennai District; On-site; INR 600,000 - 900,000; Full time

Job summary

Jobtailor is seeking a Regulatory Affairs professional to support License Renewals and Annual Reports. The role involves coordinating CMC submissions across global markets, preparing contributions for renewal applications, and ensuring compliance with U.S. regulatory guidelines.

The candidate will work with Pfizer-related procedures, manage dossier reviews, and assist in regulatory strategy for renewals, contributing to accurate and timely AR filings and regulatory submissions.

Qualifications

• Postgraduate in Pharmacy or Science with relevant regulatory exposure.
• 1 year or less of independent regulatory affairs leadership experience in pharma.
• Strong English communication (oral and written) and detail orientation.
• Familiarity with post-approval changes and AR submissions for US markets.

Responsibilities

• Provide support to the Brands CMC Strategist for license renewals and ARs.
• Coordinate with GRS-CMC and cross-functional teams for global submissions.
• Manage day-to-day regulatory activities within agreed timelines.
• Authors and compiles CMC contributions for renewal and AR submissions (Modules 1, 2.3.S/P, 3.2.S/P/R/A).
• Review and update dossier components; identify risks and mitigation actions.

Skills

Regulatory Affairs

CMC Contributions

US Regulatory Guidelines

Pharmaceutical Manufacturing

Regulatory Strategy

Education

Postgraduate in Pharmacy/Science

Tools

PEARL

GDMS

PDM

SPA

Job description

• Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team
• Works closely with the CMC Global Regulatory Strategist - CMC (GRS-CMC) and cross-functional teams to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets
• Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed timelines
• Provides support in preparing CMC contributions for renewal applications across global markets
• Authors and/or compiles CMC contributions for renewal applications, including Modules 1, 2.3.S/P, and 3.2.S/P/R/A
• Liaises with Pfizer Global Supply and other support functions
• Applies relevant regulatory guidelines for renewal documentation
• Executes regulatory strategy for renewals and seeks endorsement from GRS-CMC and/or RRHS
• Reviews technical and supporting information for renewal submissions
• Updates impacted dossier components and contributes to risk identification and mitigation
• Coordinates Module 1 and Module 3.2.R ancillary documents
• Coordinates internal document review and sign-off activities
• Reviews reporting-period changes for Annual Reports and develops initial Annual Report regulatory strategy
• Authors and/or compiles Annual Report CMC contributions based on applicable changes
• Reviews systems to confirm post-approval changes, commitments, and fulfillment
• Reviews technical and supporting information for Annual Report changes
• Manages and reviews stability contributions
• Applies U.S. regulatory guidelines to confirm Annual Report filing classifications
• Develops technical justifications for agency submission
• Ensures compliance with Pfizer internal procedures and training SOPs (PLA)
• Utilizes Pfizer systems including PEARL, GDMS, PDM, and SPA

Requirements

• Minimum – Postgraduate in Pharmacy / Science
• Minimum 0 - 1 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
• Excellent oral and written English communication skills
• Good conceptual, analytical, problem solving, and organizational skills
• Good conceptual and reasoning skills
• Attention to details
• Regulatory requirements of post approval changes for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs
• Knowledge in retrieving information from company's and regulatory agency databases
• Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry

Core Competencies

Demonstrates expertise in Regulatory Affairs with a focus on CMC contributions for License Renewals and Annual Reports, ensuring compliance with U.S. regulatory guidelines and Pfizer internal procedures. Proficient in managing regulatory activities, authoring documentation, and collaborating with cross-functional teams to support global market submissions.

Highest-signal resume keywords

• Regulatory Affairs
• CMC Contributions
• U.S. Regulatory Guidelines
• Pharmaceutical Manufacturing
• Regulatory Strategy

Hard Skills

• Regulatory Requirements
• Post-Approval Changes
• Technical Justifications
• Dossier Management