Associate I-Reg CMC Strategy

Pfizer; India; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Pfizer India seeks an individual to provide functional support to the Brands CMC Strategist for Renewal and Annual Report submissions across global markets. Role collaborates with GRS-CMC and cross-functional teams to prepare and submit CMC contributions within defined timelines.

The incumbent will handle day-to-day regulatory activities for Renewals and ARs under TL guidance, use Pfizer systems, and ensure accuracy and timeliness of regulatory documentation.

Qualifications

• Postgraduate in Pharmacy/Science is preferred.
• Excellent English communication, written and verbal.
• Experience in regulatory affairs and document preparation.

Responsibilities

• Prepare and submit CMC contributions for renewal and AR applications.
• Coordinate Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A activities.
• Liaise with GRS-CMC, RRHS and other functions to meet timelines.
• Review systems and update dossier components; ensure compliance.

Skills

English communication

Analytical skills

Reasoning skills

Attention to detail

Regulatory knowledge

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. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Regulatory Affairs Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.