Regulatory Manager

Bristol Myers Squibb • Full-time • 北京市, CN • 1w ago

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Take the responsibility for implementing and delivering regulatory submission and approval and maintenance for products / projects within agreed timeline. Ensure regulatory compliance with government policy and company required SOPs
Establish and maintain close relationship with NMPA/ CDE/ NIFDC and other appropriate regulatory agencies and under manager’s guidance have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to NMPA.
Conduct scientific discussion with relevant external and internal scientific functions locally and globally, specifically, global CMC and GRS Operation, Pharmaceutical Development, Pre-Clinical etc.
Maintain good knowledge in general/product specific scientific and regulatory requirement/ process including importation and local production.
Maintain strong working relationship and communications with cross-functions to provide regulatory information and support.

Provide support to Policy & Intelligent management or Database development, update and maintain and training execution.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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R1608031 Regulatory Manager