# Regulatory CMC Strategist

**Company**: Pfizer
**Location**: Mumbai
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Mumbai/Associate-Manager-I---Reg-CMC-Strategy--NP-CMC-Support_4966881?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

We are seeking a Regulatory CMC Strategist to provide functional support to the Regulatory CMC Strategist for the Annual Reports & License Renewals, Innovative Products Team.

The successful candidate will work closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets.

**Responsibilities:**

- Manage day‑to‑day work activities associated with assigned renewal applications within agreed‑upon timelines

- Develop renewal regulatory strategies while considering registered content

- Prepare CMC contributions for renewal applications for assigned products across global markets

- Coordinate Module 1 and Module 3.2.R ancillary documents

- Review technical and supporting information for submission to support renewal applications

- Develop technical justifications for changes for agency submissions

- Support / Author query responses and/or commitment management

- Liaise with Pfizer Global Supply and other support functions

- Review and apply relevant regulatory guidelines for authoring renewal documentation

- Make decisions to resolve minor to moderate issues in standard situations

- Coordinate internal document review and sign‑off activities

- Utilize Pfizer systems to build expertise and guide or mentor colleagues

- Ensure compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates

**Requirements:**

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

- 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

- 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

**Technical Skills:**

- Regulatory requirements of post approval changes for global market

- Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals

- 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

## Skills

### Required
- regulatory affairs
- pharmacy
- biotechnology
- CMC strategy
- legislation

### Nice to have
- leadership
- communication
- analytical skills
- problem-solving skills

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