Pfizer is hiring for the position of Associate II – Reg Strategy, GRS Oncology in Chennai, Tamil Nadu. The role is part of the Regulatory Affairs function and focuses on regulatory strategy, lifecycle maintenance submissions, CMC submission operations, Health Authority support, labeling, safety compliance, and cross-functional collaboration.
The position is suitable for candidates with a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline, with preferably 2–4 years of relevant pharmaceutical industry experience.
Job Details
| Job Details | Information |
|---|---|
| Company | Pfizer |
| Job Role | Associate II – Reg Strategy, GRS Oncology |
| Job Requisition ID | 4964681 |
| Job Function | Regulatory Affairs |
| Job Location | Chennai, Tamil Nadu, India |
| Additional Location | APAC – Any Pfizer Site |
| Job Type | Full Time |
| Work Arrangement | Hybrid |
| Experience | Preferably 2–4 years of relevant pharmaceutical industry experience |
| Qualification | Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related discipline |
Positions
Associate II – Reg Strategy, GRS Oncology
Responsibilities
Selected candidates will be responsible for:
- Coordinating lifecycle activities including variations, supplements, amendments, renewals, withdrawals, post-approval commitments, and other maintenance submissions.
- Supporting regional regulatory strategies for assigned projects and products.
- Coordinating regulatory positions and submission approaches across global, regional, and country stakeholders.
- Authoring and quality-checking electronic applications, cover letters, and submission packages.
- Performing quality checks of eAF CMC content for completeness, accuracy, and alignment with approved regulatory strategies and source documents.
- Supporting process simplification, automation, and continuous improvement of eAF and CMC regulatory workflows.
- Preparing and coordinating submission components including application forms, response documents, commitments, declarations, product information, and administrative documents.
- Supporting responses to Health Authority questions by coordinating inputs and consolidating comments.
- Coordinating core and local labeling updates, submission planning, implementation tracking, and reconciliation.
- Supporting aggregate reports, risk-management documents, and post-authorization safety or efficacy commitments.
- Generating Pearl reports and WWRS reports for safety compliance reports, renewals, launches, and Health Authority queries as required.
- Collaborating with Global Regulatory Leads, CMC Regulatory, clinical, safety, labeling, quality, supply, commercial, publishing, and country regulatory teams.
- Participating in regulatory project and sub-team meetings and following up on assigned actions.
- Contributing to knowledge sharing, coaching, process improvement, and team collaboration.
Eligibility / Qualifications
Candidates should have:
- A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline.
- Preferably 2–4 years of relevant pharmaceutical industry experience.
- Working knowledge of pharmaceutical regulatory submissions and product lifecycle management.
- Experience preparing, coordinating, or reviewing regulatory submission documents.
- Experience maintaining regulatory data or trackers.
- Ability to manage multiple priorities in a complex global matrix environment.
- Strong attention to detail and ability to work with appropriate independence.
- Strong written and verbal communication skills.
- Ability to communicate technical and regulatory information clearly to different stakeholders.
- Ability to communicate complex information and analyses to scientific audiences and senior management.
- Effective presentation skills across individual, small-group, and large-group settings.
Preferred Qualifications
- Master’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related discipline.
- Experience supporting oncology, specialty care, biologics, or other complex product portfolios.
- 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 regulatory frameworks and submission procedures, including EM, EU, and/or US requirements.
- Experience with process improvement, data analytics, automation, or approved AI tools in a regulated environment.
Required Skills
Key skills relevant to the role include:
- Regulatory Affairs
- Regulatory submissions
- Regulatory strategy
- Product lifecycle management
- CMC submissions
- eAF
- Health Authority responses
- Regulatory data management
- Labeling activities
- Safety compliance reporting
- Post-approval variations
- Renewals
- Cross-functional collaboration
- Stakeholder communication
- Quality checking
- Process improvement
- Data analytics and automation
Application Details
