Use Your Power for Purpose

At Pfizer, our mission is to deliver breakthroughs that transform patients’ lives. As a Senior Manager, your work will be at the heart of our efforts to convert advanced science and innovative technologies into impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring the safety and efficacy of drugs, or supporting clinical trials, you will leverage cutting-edge design and process development skills to expedite and deliver top-tier medicines to patients globally.

What You Will Achieve

In this role, you will:

• Take Regulatory CMC lead to support products at various stages including clinical trial application, NDA and post approval variations
• Serve as a primary regulatory CMC contact 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.
• Ensure high quality CMC submissions in compliance with China regulations and guidelines. Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Manage regulatory issues, maintain submission information in relevant GRS CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects. Mentoring colleagues may be expected within focus area of expertise.
• Manage and Contribute to GRS CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
• Demonstrate 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.
• Develop effective relationships with local & global internal partners, e.g. GRS CMC, China RA, DC and PGS.
• Develop relationships with regulatory authorities and network with pharmaceutical industrial associations to improve Pfizer’s regulatory success and enhance Pfizer’s image.

Here Is What You Need (Minimum Requirements)

• BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.

• Technical discipline with 8+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience are desired.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.