Manager - RegCMC, Medical Devices (Chennai)

Manager - RegCMC, Medical Devices (Chennai)

10 Aug
|
Pfizer
|
Chennai

10 Aug

Pfizer

Chennai

Use Your Power for Purpose
In an ever-changing regulatory environment, Pfizer relies on a knowledgeable and skilled Regulatory Affairs team. As part of this agile team, you will review and interpret increasing regulatory requirements and their associated commercial pressures to ensure the best patient care. Our patients depend on dedicated colleagues like you, experts in your field, who prioritize their well-being above all else. Your work will have a direct impact on ensuring that our products meet the highest standards of safety and efficacy, ultimately contributing to the health and well-being of patients worldwide.

What You Will Achieve
In this role, you will:
develop effective relationships with local & global internal partners, i.e., R&D; (PTx, BTx), PGS, GRS, BU’s, etc.
Primarily support the maintenance and post-approval changes of Pfizer's on-market portfolio for combination products, ensuring all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.




Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
Execute training related activities (e.g. compliance-related, HR policies…), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
Manage regulatory issues, maintain submi

📌 Manager - RegCMC, Medical Devices (Chennai)
🏢 Pfizer
📍 Chennai

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