Global Regulatory Affairs (GRA) Fellow

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Education Required:

Candidate should have completed aDoctor of Pharmacy (PharmD),Master’sin RegulatoryAffairs,or aPh.D.in life sciencesby July 2027.

General Description:

The BeOne Medicines Global Regulatory Affairs (GRA) Fellow willengage in aone-year rotational programthat includes working in various departments within GRA to support BeOne regulatory drug development inGlobal Regulatory Policy and Intelligence (GRPI), Regulatory Strategy,Advertising and Promotion, and Labeling.The Fellow will apply their scientific knowledge,regulatorylearningsand independent judgmenttosupport andexecutekey deliverables for each sub-function.These key deliverables,presentationsand projects inform important regulatorystrategy. Effective communication, both written and verbal,and critical thinking arevitalskillsfor this role.The fellowship will be conducted remotely beginning July 2027.

**When applying, please upload curriculum vitae (CV), letter of intent, and your unofficial college transcript**

Essential Functions of the job:

The GRA Fellow will rotate throughout the Global Regulatory Affairs Department in thefourbelowsub-departmentsand perform the tasksidentifiedbelowunder the supervision of each respective sub-department:

Global Regulatory Policy and Intelligence (GRPI)

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The GRPI team analyzes and presents the latest in health authority regulatory trends, policy initiatives, and approvals across therapeutic areas.

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The fellow willcompletetimelyand thorough analyses of nuances of regulatory precedents along with tracking dynamic regulatoryenvironmentto support BeOnepipeline products.

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Using critical analysis, problem-solving and writing skills, the fellow willwork onGRPI deliverables (examples areregulatory background packages, competitive benchmarking summaries,regulatorystrategy questions, and regulatorytopic analyses, etc.).

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Fellowwillcreate presentations andpresent onrelevantregulatorytopicsatinternalforums.

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Fellowwill recruit and promote forpotential future GRA fellowship recruitment cycle during their fellowship year.

Global Regulatory Affairs - Strategy

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The regulatory strategy team plans and coordinates regulatory submissions and provides guidance to the cross-functional development teams on regulatory strategy and tactics.

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The fellow willpartner closely withthe regulatory affairsstrategylead(s)bysupporting the developmentand implementationstrategies foroptimalregulatory development of BeOne pipeline drug development programs.

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Fellowwillutilize GRPI deliverables toassess regulatorylandscapeto address regulatory challenges.

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Fellowmay support creation ofimportant communications with health authorities includingnew INDs, cover lettersdescribing the submission, and supportNDAs/BLAs.

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Global Regulatory Affairs - Advertising and Promotion

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The regulatory advertising and promotion team administers the promotional review process, prepares FDA submissions for promotional materials, and provides regulatory review and oversight for promotional and non-promotional product communications.

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The fellow willapplyFDA regulatory requirements for promotion and other product related communications.

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Fellowwillactivelyparticipateininternalcross-functional Promotional Review Committee (PRC) Meetings.

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Fellowwillreviewpromotionalmaterials under supervision of regulatory advertisement and promotion staff memberfor new productsand/or new indication launches.

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Global Regulatory Affairs-Labeling

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The labeling team develops andmaintainsglobal core labeling for commercial products and provides regulatory support for local labeling development and implementation.

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