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Associate I-Reg CMC Strategy

By Admin · Regulatory Affairs

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

ROLE OVERVIEW

Provide regulatory CMC strategy and documentation support for product license renewals and annual reports across global markets, with a focus on post-approval regulatory requirements.

ROLE DEFINITION & RESPONSIBILITIES

  • •Support preparation of CMC contributions for global renewal applications
  • •Author and compile Modules 1, 2.3.S/P and 3.2.S/P/R/A
  • •Apply relevant regulatory guidelines to renewal documentation
  • •Review technical and supporting information and update impacted dossier components
  • •Review post-approval changes and develop Annual Report regulatory strategies
  • •Author and compile Modules 1 and 3 contributions for Annual Reports
  • •Review stability contributions and determine appropriate filing classifications
  • •Develop technical justifications for agency submissions
  • •Coordinate internal document review and sign-off activities
  • •Use Pfizer CMC and regulatory systems including GDMS, PDM and SPA
Reporting Hierarchy: Works under the guidance of a Team Lead or designee; Supports Brands CMC Strategists and works closely with CMC Global Regulatory Strategists, RRHS, PCO, RCM, Site CNM and Pfizer Global Supply; Escalates risks and timeline issues to CMC regulatory leadership

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

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Postgraduate degree in Pharmacy or Science
  • 0-1 years of Regulatory Affairs experience in a reputed pharmaceutical organization
  • Good oral and written English communication
  • Good conceptual and reasoning skills
  • Strong attention to detail

PREFERRED QUALIFICATIONS

  • •Knowledge of U.S. post-approval regulatory requirements
  • •Experience with oral solid dosage and sterile injectable manufacturing/regulatory data
  • •Familiarity with regulatory agency and company databases
  • •Knowledge of pharmaceutical manufacturing processes and policies
  • •Analytical and problem-solving skills

REQUIRED VERIFIED SKILLS

CMC regulatory strategy
Regulatory Affairs
license renewals
Annual Reports
post-approval changes
regulatory submissions
CTD Modules
U.S. regulatory guidelines
dossier management
stability data
technical justification
regulatory databases
document review
risk management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development and learning opportunities; exposure to global regulatory activities; cross-functional collaboration within a global pharmaceutical organization
The posting does not disclose a salary range or bonus/equity amount; compensation should therefore be treated as undisclosed.

ORGANIZATION CONTEXT & CULTURE

Pfizer is a global pharmaceutical company focused on discovering, developing and delivering medicines and vaccines to address serious health conditions worldwide.

TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
Culture: Culture emphasizes scientific innovation, collaboration, inclusion, compliance, continuous learning and patient-focused impact.

EXPECTED CAREER ROADMAP

Potential progression into Regulatory Affairs Specialist, CMC Regulatory Strategist, Regulatory CMC Manager and broader global regulatory leadership roles.

APPLICATION ADVISORY

Highlight postgraduate Pharmacy/Science education; emphasize any Regulatory Affairs exposure even within 0-1 years; demonstrate knowledge of U.S. post-approval changes and CMC documentation; showcase attention to detail, analytical ability and English communication; mention familiarity with CTD modules, stability data and regulatory databases.
RECOMMENDED TRAINING
1/5
CMC Regulatory Affairs Certification

CMC Regulatory Affairs Certification

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