China Regulatory CMC Lead
1 month ago
Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled and experienced China Regulatory CMC Lead to join our team.
Key Responsibilities- Ensure regulatory compliance with government policy and company required SOPs.
- Support the Head of Regulatory Affairs to develop a competitive regulatory strategy to ensure products are registered in China.
- Retain an effective regulatory CMC team, oversee China regulatory CMC projects/activities/communication.
- Continually improve the CMC-TA working model to enhance team working efficiency and collaboration.
- Lead the China CMC team to develop optimal CMC regulatory strategy & execution based on regulatory requirements.
- Lead and facilitate centralized CMC regulatory projects and general CMC issues to address challenges in product review and approval process.
- CMC knowledge sharing and training.
- Work closely with industry associations to cooperate for CMC regulatory assessment and exert external influence to shape the regulatory environment in China.
At Bristol Myers Squibb, we offer a unique and challenging work environment that allows our employees to grow and thrive. We are committed to diversity, inclusion, and employee well-being. Our company culture is built on the values of passion, innovation, urgency, accountability, inclusion, and integrity.
We are an equal opportunities employer and welcome applications from diverse candidates. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, please direct your inquiries to.
We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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