PHARMAFull-time
Associate II Reg Strategy, GRS Oncology
CHENNAI (IN)HYBRIDPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Support global regulatory strategy and lifecycle maintenance activities for oncology products, coordinating submissions, CMC Module 1 documentation, labeling, safety compliance activities, Health Authority responses, and cross-functional regulatory operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Coordinate lifecycle regulatory activities including variations, supplements, amendments, renewals, withdrawals, and post-approval commitments
- •Lead and implement regional regulatory strategies with relevant stakeholders and commercial objectives
- •Author and quality-check electronic applications, cover letters, and CMC submission packages
- •Perform quality checks of eAF CMC content for completeness, accuracy, consistency, and alignment with regulatory strategy
- •Prepare and coordinate submission components including application forms, response documents, commitments, declarations, product information, and administrative documents
- •Coordinate inputs and support responses to Health Authority questions within agreed timelines
- •Coordinate core and local labeling updates, impact assessments, submission planning, implementation tracking, and reconciliation
- •Support aggregate reports, risk-management documents, and post-authorization safety or efficacy commitments
- •Generate Pearl and WWRS reports as needed for safety compliance, renewals, launches, and Health Authority queries
- •Collaborate with global, regional, country, CMC, clinical, safety, labeling, quality, supply, commercial, and publishing teams
- •Contribute to process simplification, standardization, automation, knowledge sharing, and team development
Reporting Hierarchy: Reports to Global Regulatory Strategy leadership within a global matrix organization; Exact manager title and team size are not specified in the source posting
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or master's degree in pharmacy, life sciences, chemistry, biotechnology, or related discipline
- Preferably 2-4 years of relevant pharmaceutical industry regulatory experience
- Working knowledge of pharmaceutical regulatory submissions and product lifecycle management
- Experience preparing, coordinating, or reviewing regulatory submission documents and maintaining regulatory data or trackers
- Ability to manage multiple priorities in a complex global matrix environment
- Strong written, verbal, analytical, and presentation communication skills
PREFERRED QUALIFICATIONS
- •Master's degree in pharmacy, regulatory affairs, life sciences, or related discipline
- •Oncology, specialty-care, biologics, or complex-product experience
- •Hands-on experience with post-approval variations, renewals, labeling changes, Health Authority responses, or CMC submissions
- •Experience with eAF, product data management, electronic submission tools, document-management systems, or regulatory information management systems
- •Knowledge of major US, EU, or other international regulatory frameworks
- •Experience with process improvement, data analytics, automation, or approved AI tools in regulated environments
REQUIRED VERIFIED SKILLS
Regulatory strategy
Regulatory submissions
Lifecycle management
CMC
Module 1
eAF CMC
Post-approval variations
Renewals
Supplements
Amendments
Withdrawals
Health Authority responses
Regulatory labeling
Safety compliance reports
Aggregate reports
Risk management
Regulatory data management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Pfizer benefits and employee support programs; specific benefits vary by location and employment terms
The source posting does not disclose a salary range or bonus/equity amount. Salary figures have therefore not been inferred.
ORGANIZATION CONTEXT & CULTURE
Pfizer is a global biopharmaceutical company focused on discovering, developing, manufacturing, and delivering medicines and vaccines. Its regulatory organization supports compliant product development, lifecycle management, and patient access across global markets.
TEAM SIZE: 100,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
Culture: Pfizer emphasizes scientific excellence, integrity, collaboration, regulatory compliance, patient access, critical thinking, agility, and cross-functional partnership.
EXPECTED CAREER ROADMAP
The role can progress into senior regulatory strategy, regional regulatory lead, global regulatory strategy, CMC regulatory, or broader product lifecycle regulatory leadership positions. Experience with oncology products, global submissions, Health Authority interactions, labeling, safety compliance, and process automation can broaden long-term regulatory career opportunities.
APPLICATION ADVISORY
Emphasize 2-4 years of pharmaceutical regulatory experience and hands-on lifecycle submission exposure; highlight experience with variations, renewals, labeling, CMC Module 1, Health Authority responses, and regulatory trackers; demonstrate strong technical writing, presentation, stakeholder-management, and prioritization skills; highlight oncology, biologics, or specialty-care exposure where applicable; mention experience with eAF, electronic submissions, regulatory information systems, automation, or analytics if available.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.