Global Regulatory Affairs (GRA) Fellow

BeiGene

5d•Remote

About The Position

The BeOne Medicines Global Regulatory Affairs (GRA) Fellow will engage in a one-year rotational program that includes working in various departments within GRA to support BeOne regulatory drug development in Global Regulatory Policy and Intelligence (GRPI), Regulatory Strategy, Advertising and Promotion, and Labeling. The Fellow will apply their scientific knowledge, regulatory learnings and independent judgment to support and execute key deliverables for each sub-function. These key deliverables, presentations and projects inform important regulatory strategy. Effective communication, both written and verbal, and critical thinking are vital skills for this role. The fellowship will be conducted remotely beginning July 2027.

Requirements

Candidate should have completed a Doctor of Pharmacy (PharmD), Mater’s in Regulatory Affairs, or a Ph.D. in life sciences by July 2027.
Strong problem-solving skills are essential to interpret complex regulations, assess their impact on organizational processes, and develop strategies to meet evolving regulatory demands.
Clear written and verbal communication is critical for drafting regulatory documents, explaining requirements to stakeholders, and liaising with regulatory authorities.
Prioritizes work activities and uses time efficiently and completes tasks accurately. Follows instructions and responds to management direction.
The ability to stay updated on changing regulations, manage shifting priorities, and navigate ambiguity is vital in dynamic regulatory environments.
The ability to creatively navigate regulatory constraints and propose forward-thinking solutions, such as leveraging emerging technologies or streamlining processes.
Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva).

Nice To Haves

Professional work experience
Industry related experience
Leadership experience
Publications / Poster Presentations/Research

Responsibilities

Complete timely and thorough analyses of nuances of regulatory precedents along with tracking dynamic regulatory environment to support BeOne pipeline products.
Work on GRPI deliverables (examples are regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses, etc.) using critical analysis, problem-solving and writing skills.
Create presentations and present on relevant regulatory topics at internal forums.
Recruit and promote for potential future GRA fellowship recruitment cycle during their fellowship year.
Partner closely with the regulatory affairs strategy lead(s) by supporting the development and implementation strategies for optimal regulatory development of BeOne pipeline drug development programs.
Utilize GRPI deliverables to assess regulatory landscape to address regulatory challenges.
Support creation of important communications with health authorities including new INDs, cover letters describing the submission, and support NDAs/BLAs.
Apply FDA regulatory requirements for promotion and other product related communications.
Actively participate in internal cross-functional Promotional Review Committee (PRC) Meetings.
Review promotional materials under supervision of regulatory advertisement and promotion staff member for new products and/or new indication launches.
Apply regulatory labeling strategies and operations, and support activities for management and governance of global and local product labeling.
Review and assess any developments (i.e., new indications, safety issues) and update/maintain global and local product labeling and Company Core Data Sheet (CCDS).
Conduct labeling comparisons of potential new product and/or new indication launches by analyzing labels (USPI and SmPC).