Associate II – Reg CMC Strategy

Jobtailor; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Jobtailor in Chennai seeks a Regulatory Affairs professional to lead CMC contributions for license renewals and annual reports across global markets. You will coordinate cross‑functional teams, author technical justifications, and ensure timely submissions in alignment with Pfizer procedures.

The role requires 2–4 years in regulatory affairs, strong English communication, and attention to detail. You will work with global regulatory partners and utilize PEARL, GDMS, PDM, and SPA systems to

Qualifications

• Undergraduate or postgraduate in Pharmacy or Science.
• 2–4 years in leading regulatory affairs in a reputed Pharmaceutical Organization.
• Excellent oral and written English communication skills.
• Good conceptual, analytical, problem solving, and organizational skills.
• Knowledge on Regulatory requirements of post approval changes for global market.
• Familiarity with Pfizer internal procedures and training SOPs (PLA).

Responsibilities

• Provides functional support to the Brands CMC Strategist for License Renewals and Annual Reports.
• Prepares and submits CMC contributions for Renewal and Annual Report applications across global markets.
• Manages day‑to‑day regulatory activities within agreed timelines.
• Authors and compiles CMC contributions for renewals (Modules 1, 2.3.S/P, 3.2.S/P/R/A).
• Coordinates internal document reviews and sign‑off activities.
• Reviews changes implemented during the reporting period for completeness and accuracy.
• Develops initial Annual Report regulatory strategy and authors CMC contributions.
• Ensures post‑approval changes are submitted and approvals tracked in Pfizer systems (PEARL, GDMS, PDM, SPA).

Skills

Regulatory Affairs

CMC contributions

Regulatory strategy

US regulations

Attention to detail

Education

Undergraduate/Postgraduate in Pharmacy or 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 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
• Supports preparation of CMC contributions for renewal applications across global markets
• Authors and/or compiles CMC contributions for renewals, 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 in renewal documentation
• Executes regulatory strategy for renewals and supports query and commitment management
• Reviews technical and supporting information for renewal submissions
• Updates impacted dossier components and supports risk identification and mitigation
• Coordinates Module 1 and Module 3.2.R ancillary documents
• Coordinates internal document review and sign-off activities
• Reviews changes implemented during the reporting period for completeness and accuracy
• Develops initial Annual Report regulatory strategy and authors or compiles CMC contributions
• Reviews systems to confirm post-approval changes submitted and approved, including commitments made and fulfilled
• Manages and reviews stability contributions
• Reviews and applies relevant U.S. regulatory guidelines for Annual Reportable filing classifications
• Develops technical justifications for agency submission as needed
• Ensures compliance with Pfizer internal procedures and training SOPs (PLA)
• Utilizes Pfizer systems including PEARL, GDMS, PDM, and SPA

Requirements

• Minimum – Undergraduate/Postgraduate in Pharmacy or Science
• Minimum 2 - 4 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
• Knowledge on Regulatory requirements of post approval changes for global market
• 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
• Compliance with Pfizer internal procedures and training SOPs (PLA)

Core Competencies

Demonstrates expertise in Regulatory Affairs with a focus on CMC contributions for License Renewals and Annual Reports, ensuring compliance with global regulatory guidelines and Pfizer internal procedures. Proficient in managing regulatory activities, coordinating document reviews, and executing regulatory strategies effectively.

Highest-signal resume keywords

• Regulatory Affairs Experience
• CMC Contributions Authoring
• Regulatory Strategy Execution
• Knowledge of U.S. Regulatory Guidelines
• Attention to Detail

ATS Optimization Keywords

Hard Skills

• Regulatory Requirements Knowledge
• Post-Approval Changes Management
• Technical Justification Development
• Dossier Component Updates
• Stability Contributions Management

Soft Skills

• Excellent Communication Skills
• Analytical Skills
• Problem Solving Skills
• Organizational Skills

Industry Keywords

• Pharmaceutical Industry
• Regulatory Guidelines
• Compliance
• Annual Report
• License Renewals

Tools & Technologies

• PEARL
• GDMS
• PDM
• SPA