Associate I-Reg CMC Strategy

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

Job summary

Pfizer in Chennai is seeking a Regulatory Affairs professional to support Renewal and Annual Report activities. You will author and compile CMC contributions, coordinate Module 1 and 3.2.R documents, and ensure submissions are on time.

You will liaise with GRS-CMC, RRHS, and cross‑functional teams to maintain accuracy and compliance. The role requires a postgraduate in Pharmacy or Science with 0–1 year in regulatory affairs, and strong English communication and meticulous attention to detail.

Qualifications

• Postgraduate in Pharmacy or Science required.
• 0–1 year experience in regulatory affairs in pharma preferred.
• Excellent English communication, both written and spoken.
• Strong attention to detail and good organizational skills.

Responsibilities

• Provide day‑to‑day regulatory support for Renewals and AR CMC teams.
• Prepare and compile CMC contributions for renewal/annual report submissions.
• Coordinate Module 1 and Module 3.2.R ancillary documents.
• Review and update dossier components; escalate risks and delays.
• Utilize Pfizer systems (PEARL, GDMS, PDM, SPA) for submissions and reviews.

Skills

Regulatory affairs

English communication

Attention to detail

Documentation

Education

Postgraduate in Pharmacy/Science

Tools

PEARL

GDMS

PDM

SPA

Job description

**JOB SUMMARY**Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team, working closely with the CMC Global Regulatory Strategist – CMC (GRS‐CMC) and cross‐functional teams (RRHS/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.**JOB RESPONSIBILITIES**Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed upon timelines under the guidance of Team Lead / designee.**Renewals** **CMC Responsibilities:**Demonstrates Fundamental Knowledge of Process Principles and Concepts; Activities Include, but Are Not Limited to:* Provides support to Renewal Strategists in the preparation of CMC contributions for renewal applications for assigned products across global markets.* Authors and/or compiles CMC contributions for renewals (e.g., Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A); collaborates with GRS‐CMC and RRHS, as appropriate, and within agreed timelines.* Liaises with Pfizer Global Supply and other support functions, as needed.* Applies relevant regulatory guidelines for authoring renewal documentation.* Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‐CMC and/or RRHS.* Reviews technical and supporting information for submission to support renewal applications.* Updates impacted dossier components, as required; escalates timeline delays and contributes to the identification and mitigation of risks with support from the Team Lead (TL) or designee; flags identified risks to the CMC GRL and/or appropriate leadership.* Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.* Coordinates internal document review and sign‐off activities.* Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.**Annual Report (AR) CMC Responsibilities:*** Reviews changes implemented during the reporting period for completeness and accuracy; develops the initial Annual Report regulatory strategy while considering registered content and seeks endorsement from the CMC GRL.* Authors and/or compiles CMC contributions based on changes made during the applicable reporting period (e.g., Modules 1 and 3), under the guidance of the CMC GRL, within agreed timelines.* Reviews all relevant systems to confirm post‐approval changes submitted and approved, including commitments made and fulfilled.* Reviews technical and supporting information for submission to support Annual Report changes.* Manages and reviews stability contributions to ensure accuracy and consistency with approved commitments.* Reviews and applies relevant U.S. regulatory guidelines to confirm appropriate Annual Reportable filing classifications.* Develops technical justifications for changes for agency submission, as needed.* Updates impacted dossier components, as required.* Coordinates Module 3.2.R ancillary documents, as needed.* Escalates timeline delays and flags identified risks to the CMC GRL and/or appropriate leadership.* Coordinates internal document review and sign‐off activities.* Utilizes Pfizer CMC systems (e.g., GDMS, PDM, SPA), as appropriate.* Ensures compliance with Pfizer internal procedures and training SOPs (PLA).**QUALIFICATIONS** **/** **SKILLS**Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.* **Preferred Education:**Minimum – Postgraduate in Pharmacy / Science* **Preferred Experience:**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 and reasoning skills. Attention to details.* **Preferred Attributes:**Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.* **Technical Skills:** + 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.