Associate Manager I – Reg CMC Strategy

Jobtailor; Chennai District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Pfizer is seeking a Regulatory Affairs professional with CMC expertise to lead post-approval change management and strategy development. The role requires coordination with global teams to ensure timely delivery of submissions and responses to health authorities.

The candidate should have a postgraduate degree in pharmacy or science and 3–7 years of CMC regulatory experience, with strong communication skills and ability to work in a matrixed environment.

Qualifications

• Postgraduate in Pharmacy or Science.
• 3–7 years of CMC experience within regulatory function.
• Knowledge of EU/US and international regulatory practices.
• Proficiency with submission management tools, DMS, publishing tools and databases.
• Strong verbal and written communication; adaptable and deadline-driven.
• Team player in a matrixed environment.

Responsibilities

• Execute CMC strategies for post-approval changes globally.
• Develop and execute regulatory strategies, including responses to health authority queries.
• Manage day-to-day regulatory activities for assigned PCFs within timelines.
• Collaborate with cross-functional teams and GRS-CMC to ensure deliverables.
• Author and compile Regulatory Strategy Documents and global CMC submission packages.

Skills

Regulatory strategy

CMC experience

Cross-functional collaboration

Verbal & written communication

Time management

Education

Postgraduate in Pharmacy or Science

Tools

Trackwise

Navigation tools

Document management systems

Publishing tools

Databases

Job description

• Execute CMC strategies for Pfizer Global Supply-initiated prioritized post-approval changes globally in collaboration with CMC GRS
• Develop and execute regulatory strategies, including responses to health authority queries
• Manage day-to-day regulatory activities for assigned PCFs within agreed timelines
• Collaborate with cross-functional teams and GRS-CMC to ensure deliverables
• Function as CMC author/strategist for minor and moderate post-approval changes, projects, and products
• Conduct end-to-end PCF assessment
• Author and compile responses to health authority queries within agency timelines
• Review proposed changes for completeness and accuracy and develop initial global regulatory strategies
• Author and compile Regulatory Strategy Documents and global CMC submission packages, including Module 1, Module 2.3, and M3.2 S/P/R
• Review technical and supportive information for submissions and apply pertinent global regulatory guidelines
• Develop technical justifications for agency submissions
• Update M3 dossiers and coordinate M3.2.R ancillary documents
• Escalate timeline delays and contribute to risk identification and mitigation
• Resolve minor problems in standard situations and elevate complex issues and risks
• Represent the GEPRA CMC perspective and meet with stakeholders to resolve challenges
• Coordinate internal document review and sign-off
• Utilize Pfizer CMC systems including GDMS, PDM, and SPA
• Support query and commitment management with CMC GRS
• Maintain conformance systems in support of CMC GRS

Requirements

• Minimum - Postgraduate in Pharmacy or Science
• Minimum 3 to 7 years of CMC experience within a regulatory function
• Knowledge of EU/US and international regulatory practices and policies
• Proficiency in Microsoft Windows, Trackwise, Navigation or similar submission management tools, document management systems, publishing tools, and databases
• Good verbal and written communication skills
• Motivated, organized, hardworking, agile, adaptable to change, and able to meet timelines
• Team player with ability to work in a highly matrixed environment
• Customer focus and attention to detail and accuracy
• Ability to prioritize with some guidance and handle multiple projects
• Willingness to work flexible hours

Core Competencies

Demonstrates expertise in regulatory strategies and CMC processes, with a strong focus on post-approval changes and compliance with global regulatory guidelines. Proficient in managing regulatory submissions and collaborating with cross-functional teams to ensure timely delivery of projects.

Highest-signal resume keywords

• CMC Experience
• Regulatory Strategy Development
• EU/US Regulatory Knowledge
• Submission Management Tools Proficiency
• Cross-Functional Collaboration

Hard Skills

• Regulatory Strategy Documents
• Post-Approval Change Management
• PCF Assessment
• Technical Justifications for Submissions
• Global Regulatory Guidelines Application

Soft Skills

• Good Verbal and Written Communication
• Organized
• Adaptable to Change
• Customer Focus
• Attention to Detail

Certifications & Qualifications

• Postgraduate in Pharmacy or Science

Industry Keywords

• Regulatory Practices
• Health Authority Queries
• Global CMC Submission Packages
• M3 Dossiers
• Matrixed Environment

Tools & Technologies

• GDMS
• PDM
• SPA
• Trackwise
• Document Management Systems