At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.
Role Summary
In this role, you will collaborate with Global Regulatory Leads and product teams on lifecycle maintenance submissions and regulatory activities. You will represent a specific region (US, EM, or EU) and provide strategic expertise as part of the Global Regulatory Strategic Team, focusing on life cycle maintenance submission activities, CMC Module 1 document preparation, Safety compliance report and operational activities.
Key Job Responsibilities
• Regulatory strategy and lifecycle execution
• Coordinate lifecycle activities, including variations, supplements, amendments, renewals, withdrawals, post-approval commitments and other maintenance submissions for assigned regions
• Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
• Ensure regulatory positions and submission approaches are aligned across relevant global, regional and country stakeholders.
• CMC submission operations and eAF CMC process
• Author and QC electronic applications, cover letters, submission packages as requested by Strategist in support of life cycle maintenance of products
• Perform quality checks of eAF CMC content for completeness, accuracy and alignment with the approved regulatory strategy and source documents.
• Identify process gaps and contribute to simplification, automation and continu
📌 Associate II Reg Strategy, GRS Oncology (Chennai)
🏢 Pfizer
📍 Chennai
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