Mindblowing Jobs

Associate II - Reg CMC Strategy

By Admin · Regulatory Affairs

CHENNAI (IN)ONSITEPOSTED: 9/13/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
Pfizer

ROLE OVERVIEW

Support CMC regulatory strategy for global License Renewals and Annual Reports, preparing and coordinating CMC dossier contributions, applying regulatory requirements and managing submission activities under the guidance of regulatory leadership.

ROLE DEFINITION & RESPONSIBILITIES

  • •Support Renewal Strategists in preparing CMC contributions for renewal applications across global markets
  • •Author and compile CMC contributions for Modules 1, 2.3.S/P and 3.2.S/P/R/A
  • •Apply relevant regulatory guidelines and support execution of renewal regulatory strategies
  • •Review technical and supporting information and update impacted dossier components
  • •Coordinate Module 1 and Module 3.2.R ancillary documents and internal review/sign-off
  • •Review annual-report changes and develop initial CMC regulatory strategy
  • •Review post-approval changes, commitments and stability contributions for Annual Reports
  • •Apply U.S. regulatory guidelines to determine Annual Report filing classifications and prepare technical justifications
  • •Coordinate with Pfizer Global Supply and support functions and use Pfizer CMC systems such as PEARL, GDMS, PDM and SPA
  • •Escalate delays and risks and ensure compliance with Pfizer procedures and training SOPs
Reporting Hierarchy: Reports to Team Lead or designated regulatory leadership; works closely with CMC Global Regulatory Strategist, Renewal Strategists, RRHS, PCO, RCM, Site CNM and Pfizer Global Supply

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Undergraduate or postgraduate degree in Pharmacy or Science
  • Minimum 2-4 years of experience independently working in Regulatory Affairs within a reputed pharmaceutical organisation
  • Knowledge of global post-approval regulatory requirements
  • Ability to retrieve information from company and regulatory agency databases
  • Strong oral and written English communication skills
  • Good analytical, problem-solving, organisational and reasoning skills with attention to detail

PREFERRED QUALIFICATIONS

  • •Experience with global CMC regulatory strategy
  • •Experience preparing renewal applications and Annual Reports
  • •Familiarity with CMC dossier modules and post-approval changes
  • •Experience with regulatory databases and pharmaceutical manufacturing processes

REQUIRED VERIFIED SKILLS

CMC regulatory strategy
Regulatory Affairs
global regulatory requirements
post-approval changes
License Renewals
Annual Reports
CMC dossier
Module 1
Module 2.3.S/P
Module 3.2.S/P/R/A
regulatory guidelines
technical documentation
regulatory databases
stability data
risk management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard corporate benefits and professional development opportunities; specific benefits are not disclosed in the provided posting.
No salary or bonus/equity figures are disclosed in the provided job posting. Compensation should be confirmed directly with Pfizer.

ORGANIZATION CONTEXT & CULTURE

Pfizer is a global pharmaceutical company focused on discovering, developing and delivering medicines and vaccines, with regulatory and manufacturing operations supporting products across global markets.

TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
Culture: Pfizer emphasizes scientific innovation, cross-functional collaboration, regulatory compliance, quality and responsible execution across its global organisation.

EXPECTED CAREER ROADMAP

The role can progress toward Senior Regulatory Affairs/CMC roles, Regulatory Strategist positions, CMC regulatory leadership or broader global regulatory strategy careers within pharmaceutical organisations.

APPLICATION ADVISORY

Highlight 2-4 years of Regulatory Affairs experience; demonstrate global post-approval and CMC knowledge; showcase experience with renewal submissions, Annual Reports and dossier modules; mention regulatory database experience and strong documentation skills; emphasize analytical ability, attention to detail and cross-functional coordination.
RECOMMENDED TRAINING
1/5
CMC Regulatory Affairs Certification

CMC Regulatory Affairs Certification

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.