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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• The fellow willapplyregulatory labeling strategiesand operations, and support activities for management and governance of global and local product labeling.
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• Fellowwillreview and assess any developments (i.e., new indications, safety issues) and update/maintainglobal and local product labelingandCompany Core Data Sheet (CCDS).
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• Analyzing labels(USPI and SmPC), the fellow willconduct labeling comparisons ofpotential new product and/or newindicationlaunches.

Supervisory Responsibilities

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The position has no direct reports. The Fellow is part of a team that performs high quality andtimelyregulatory analyses. This position works closely withGRAas part of a matrix team.

PreferredQualifications

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

Other Qualifications

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Analyticaland CriticalThinking:Strong problem-solving skills are essential to interpret complex regulations, assess their impact on organizational processes, and develop strategies to meet evolvingregulatory demands.

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Written and VerbalCommunicationSkills:Clear written and verbal communication is critical for drafting regulatory documents, explaining requirements to stakeholders, and liaising with regulatory authorities.

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Project Management:Prioritizes work activitiesand uses time efficientlyand completes tasksaccurately.Follows instructions and responds to management direction.

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Adaptability:The ability to stay updated on changing regulations, manage shifting priorities, and navigate ambiguity is vital in dynamic regulatory environments.

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Innovation:The ability to creatively navigate regulatory constraints and propose forward-thinking solutions,such asleveragingemerging technologies or streamlining processes.

Computer Skills:Advanced application capability with Excel, PowerPoint, Word, and electronic documentmanagement system (i.e., Veeva).

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Travel

On occasion, as needed(less than 10%).

Pay Rate: 75k/Year

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $ - $ per hour

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email hidden].