China Regulatory CMC Lead

2 weeks ago

Beijing, Beijing, China Bristol Myers Squibb Full time
Transforming Patients' Lives through Science

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.

About the Role

The China Regulatory CMC Lead will be responsible for ensuring regulatory compliance with government policy and company required SOPs. This includes supporting the Head of Regulatory Affairs to develop a competitive regulatory strategy to ensure products are registered in China early. The successful candidate will also be responsible for retaining an effective regulatory CMC team, overseeing China regulatory CMC projects/activities/communication, and continually improving the CMC-TA working model to enhance team working efficiency and collaboration.

Key Responsibilities
  • Ensure regulatory compliance with government policy and company required SOPs.
  • Support Head of Regulatory Affairs to develop competitive regulatory strategy to ensure products are registered in China early.
  • Retain 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 China CMC team to develop optimal CMC regulatory strategy & execution based on regulatory requirement.
  • 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 regulatory environment in China.
What We Offer

Bristol Myers Squibb is a company that is committed to transforming patients' lives through science. We offer a unique and inclusive culture that promotes diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. We also strongly recommend that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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