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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position: Regulatory Head of China and Hong Kong

Reporting to: HQ

Location: Beijing / Shanghai

Major Responsibilities:

• Take full responsibility to be the Head of BMS China and Hong Kong Regulatory for developing/implementing regulatory strategies, and achieving regulatory submission and approval for new products/ projects in multiple therapeutic areas within agreed deliverables, ability to integrate future regulatory changes into the global development discussion with global full development team.
• Ensure regulatory compliance with government policy and company required SOPs
• Strong relationship with Director General and Divisions Heads levels of NMPA/CDE/ NIFDC and other appropriate regulatory agencies to identify potential changes/trends in regulation and be able to discuss critical issues
• Guide senior regulatory managers to conduct negotiation successfully with relevant regulatory agencies on internal agreed strategy, including but not limited to, regulatory submissions and breakthrough regulatory pathway.
• Maintain thought leader knowledge in regulatory policy, requirement and global development process of the therapeutically area (TA) of coverage
• Identify risk areas and be able lead in developing alternative approaches for programs and long term growth, including anticipation of regulator responses through scenario planning and contingency plans cross TA of responsibilities.
• Maintain strong working relationship and communications with Global Regulatory TA Head, Global Regulatory Team Leader (GRTL), Regulatory managers, Global Regulatory colleagues and members of Development Team (DT) to ensure delivery of clear/accurate messages, obtain regulatory support, resolve regulatory issues, and align a regulatory one voice.
• Enhance/maintain connection and facilitate effective communication on behalf of China GRS with the local (China DT/CEAT) and global and regional cross- functional groups by providing appropriate professional regulatory advice/ input on general regulatory requirement & process, risk and Regulatory education as well the timeline for responsible TAs and ensure these regulatory advice/input to get the consensus with GRTL, China and global DTs, and various governance committees.
• Leadership in a matrix environment to ensure high quality science-based health authority communication, work efficiency within GRS, talent development and retention.

Qualification Requirement:

• University graduate ; Pharmacy, Medical or Master or PhD in biopharmaceutical relevant subject preferred
• Working Experience:
  • Thought leader in regulatory knowledge and experiences in Regulatory in Chinese regulation and good knowledge in international regulation, as evidenced by working minimum 15 years in the MNC pharmaceutical industry or relevant government or R&D environment. Minimum 10 years regulatory experience in leading regulatory mangers for New Chemical Entities, new Biological, and MNT (Multinational Trial) stage, and has a proven track record of submission/ approval of his/her team, able to demonstrate leadership in managing independently for multiple TA or multiple disciplines in regulatory area successfully.
  • Excellent people management within regulatory and cross-functional coordination, including remote work management is the must.
  • Be viewed by internal stakeholders as TA thought leaders and be able to guide managers to lead cross-functional team for successful new development strategy and program negotiations with HA and China/global Development Team.
  • Demonstrate the ability to guide discussion on new development strategic for special topics or TA of responsibility
  • Demonstrate strong global regulatory working experiences responsible for managing multi regional regulatory activities, experience in leading global project or policy development in regulatory environment will be considered as a plus.
  • Thought leader in understanding of global/ China registration and compliance
  • Excellent oral and written communication skills (fluent in English and in Chinese)
  • Excellent resource and project planning skills
  • Excellent negotiation skills
  • Willing to travel frequently
  • Ability to build/develop relationship with external stakeholders

Personal Attributes:

• Strong critical thinking to analyze complex situations and discern critical issues

•Able to establish, build up, and sustain positive business relationship and work effectively within multicultural workforce

• Ability to manage competing priorities and driving results successfully

• Superb communication skills
• Excellent team player; but able to work independently

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting 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.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares 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.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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