Bristol Myers Squibb Regulatory Affairs Lead, Hong Kong in HONG KONG, United States

  • Decide on Local Regulatory Affairs strategic and operational matters in coordination with local business management and regional RA

  • Identify resource requirements at local level and allocate resources

  • Oversee major local RA activities ensuring early identification of conflicts between projects and the need for prioritization

  • Lead a subordinate to deliver Regulatory Affairs milestones for Hong Kong and Macau

  • Compile local submissions as needed and support local licensing activities

  • Contribute actively to design and assessment of RA strategic options

  • Provide Local RA intelligence. Identify current and emerging national regulations which impact the drug development and or marketing processes

  • Identify major clinical, technical, or operational issues impacting on successful filing, approvals and variations / maintenance. Contribute to the development of recommendations for action to address the issues

  • Provides Local RA risk estimates

  • Facilitate HA contacts and meetings as needed during the filing processes. Represent Local Regulatory Affairs at HA meetings in consultation with regional RA. Oversee communication to ensure consistency across projects

  • Represent the company as a competent reliable partner to related authorities in all regulatory matters. Build regulatory networking with national regulators, local industry organizations and key opinion leaders

  • Implement support activities as agreed with regional team

  • Initiate and track local implementation of labelling changes

  • Provide relevant information on RA milestones and documents submitted to regional team for incorporation into global databases. Ensure global and local registration database are updated

  • Act as local quality representative. Cascade communication and training to counterparts, including compliance and supply chain

  • Act as local compliance to global RA-relevant and SOPs, creation and maintenance of a local quality system including archiving, contact reporting and tracking of documents submitted. Manage training and audits of the quality system

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.