Associate II - Reg CMC Strategy

Pfizer; Chennai District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Pfizer in Chennai is seeking a Regulatory Affairs professional to support the CMC Renewals and Annual Reports team. You will work with the CMC Global Regulatory Strategist and cross-functional teams to prepare and submit CMC contributions for renewal and AR applications across global markets within defined timelines.

You will manage day-to-day regulatory activities, author and compile renewal docs, review submissions, and coordinate internal reviews using Pfizer systems.

Qualifications

• Excellent oral and written English communication skills.
• Strong analytical, problem-solving and organizational abilities.
• Attention to detail with good working knowledge of regulatory processes.

Responsibilities

• Provide CMC contributions for renewal and AR applications across global markets.
• Coordinate with CMC GRL, RRHS, and cross-functional teams to ensure timely submissions.
• Prepare Modules 1, 2/3 and ancillary documents; review and escalate timeline risks as needed.
• Utilize Pfizer systems (e.g., PEARL, GDMS, PDM, SPA) for document management and tracking.
• Ensure compliance with internal procedures and training SOPs (PLA).

Skills

English communication

Analytical skills

Organizational skills

Attention to detail

Problem solving

Education

Undergraduate/Postgraduate in Pharmacy or Science

Tools

Regulatory databases

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, including Modules 1, 2.3.S/P, and 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 in the authoring of renewal documentation.* Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‐CMC and/or RRHS; supports query and/or commitment management in collaboration with GRS‐CMC.* Reviews technical and supporting information for submission to support renewal applications.* Updates impacted dossier components, as required; escalates timeline delays and supports risk identification and mitigation in collaboration with 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 – Undergraduate/Postgraduate in Pharmacy or Science* **Preferred Experience:**Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization* **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:** + 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.