Associate Manager I - Reg CMC Strategy, NP CMC Support

Biopharma Asia; Mumbai; Hybrid; INR 1,800,000 - 3,200,000; Full time

Job summary

Pfizer seeks an experienced Regulatory Affairs professional to support CMC for Renewal and Annual Reports. The role covers development of renewal strategies, preparation of modules, and cross‑functional collaboration with GRS‑CMC, in a hybrid work setup.

You will manage day‑to‑day activities, coordinate document reviews, and ensure timely submissions across global markets while adhering to Pfizer policies and guidelines. Strong English communication and problem‑solving skills are essential.

Qualifications

• Postgraduate in Pharmacy or Science; Bachelors/Masters in Biotechnology/Pharmacy/Science or PhD.
• Minimum 4–6 years leading Regulatory Affairs in a pharma setting, handling global submissions.

Responsibilities

• Manages day-to-day renewal applications within agreed timelines and uses Pfizer systems (PEARL, GDMS, PDM, SPA).
• Develops renewal regulatory strategies with GRS‑CMC and Group Lead.
• Prepares CMC contributions for renewal submissions (Module 1, 2.3.S/P, 3.2.S/P/R/A) under guidance.
• Coordinates Module 1 and 3.2.R documents and reviews technical information for submissions.

Skills

Regulatory affairs

CMC knowledge

Documentation

Problem solving

Cross-functional collaboration

English communication

Education

Pharmacy/Science degree

Tools

PEARL

GDMS

PDM

SPA

Veeva

Job description

Provides functional support to the Regulatory CMC Strategist for the Annual Reports & License Renewals, Innovative Products Team, working closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams (RIO EH/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.

Individual Contributor – responsible for own work (requiring periodic review) under general supervision:

Renewals CMC Responsibilities:

Demonstrates Strong Knowledge and Understanding of Process Principles and Concepts; Activities Include, but Are Not Limited to:

• Manages day‑to‑day work activities associated with assigned renewal applications within agreed‑upon timelines; utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.
• Develops renewal regulatory strategies while considering registered content, in collaboration with GRS‑CMC and Group Lead.
• Prepares CMC contributions for renewal applications for assigned products across global markets; authors and/or compiles renewal documentation (e.g., Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A) under the guidance of GRS‑CMC and/or Group Lead and within agreed timelines.
• Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.
• Reviews technical and supporting information for submission to support renewal applications.
• Develops technical justifications for changes for agency submissions, as required.
• Supports / Author query responses and/or commitment management in collaboration with GRS‑CMC.
• Liaises with Pfizer Global Supply and other support functions, as needed.
• Reviews and applies relevant regulatory guidelines for authoring renewal documentation.
• Makes decisions to resolve minor to moderate issues in standard situations in accordance with guidance and policies; escalates complex issues and identified risks to GRS‑CMC, Group Lead, and/or appropriate leadership.
• Coordinates internal document review and sign‑off activities.
• Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA) to build expertise and may begin guiding or mentoring colleagues within the Renewals and/or cross‑brand teams.
• Ensures compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates.

Annual Report CMC Responsibilities:

Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.

• o Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled
• o Reviews technical/supportive information for submission to support AR changes
• o Manages and reviews stability contributions for accuracy and consistency with commitments
• o Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
• o Develops technical justification of change for agency submission as needed
• o Updates impacted dossier components as needed
• o Coordinates M3.2.R Ancillary documents as needed
• o Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership
• Coordinates internal document review and sign off.
• Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Veeva) etc., as appropriate.
• Ensures compliance to Pfizer internal procedures and training SOPs (PLA).

Preferred Education:

Minimum – Postgraduate in Pharmacy / Science Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)

Preferred Experience:

Minimum 4-6 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization handling new submissions and / or LCM submission to global health authorities especially USFDA, EMA and other EU authorities. Experience in CMC strategy and legislation that pertains to Biologics and Biosimilars is preferable.

Preferred Attributes:

Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team

Technical Skills:

• o Regulatory requirements of post approval changes for global market.
• o Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals.
• o Knowledge in retrieving information from company’s and regulatory agency databases.
• o Basiclevelofknowledgeongeneralstandards,processesandpoliciesofPfizer/Pharmaceutical manufacturing Industry.

Work Location Assignment:Hybrid

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