China Regulatory CMC Lead
4 weeks ago
Bristol Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory CMC Lead to join our team in China.
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 equal employment opportunity. We also offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about regulatory affairs and want to make a difference in patients' lives, please submit your application.
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