Global Regulatory Affairs Fellow

Job not on LinkedIn

🔥 36 minutes ago

🇺🇸 United States – Remote

💵 $75k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Complete a one-year rotational program across Global Regulatory Policy and Intelligence, Regulatory Strategy, Advertising and Promotion, and Labeling • Analyze health authority regulatory trends, policy initiatives, approvals, regulatory precedents, and the changing regulatory environment • Prepare regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses • Create and present regulatory-topic presentations at internal forums • Recruit and promote potential future GRA fellowship candidates • Support regulatory strategy development and implementation for BeOne pipeline drug development programs • Assess regulatory landscapes and address regulatory challenges using GRPI deliverables • Support communications with health authorities, including new INDs, submission cover letters, and NDAs/BLAs • Apply FDA regulatory requirements to promotional and product-related communications • Participate in internal cross-functional Promotional Review Committee meetings • Review promotional materials under supervision for new products and/or new indication launches • Support global and local product-labeling strategy, operations, management, and governance • Review developments such as new indications and safety issues and update or maintain global and local product labeling and Company Core Data Sheet • Conduct labeling comparisons of potential new product and/or new indication launches using USPI and SmPC labels • Work closely with Global Regulatory Affairs in a matrix team; position has no direct reports

🎯 Requirements

• Candidate should have completed a Doctor of Pharmacy (PharmD), Master’s in Regulatory Affairs, or Ph.D. in life sciences by July 2027 • Strong problem-solving, analytical, and critical-thinking skills • Clear written and verbal communication skills • Project management skills; prioritizes work, uses time efficiently, and completes tasks accurately • Ability to adapt to changing regulations, shifting priorities, and ambiguity • Ability to creatively navigate regulatory constraints and propose forward-thinking solutions • Advanced application capability with Excel, PowerPoint, Word, and an electronic document management system such as Veeva • CV, letter of intent, and unofficial college transcript required when applying • Professional work experience, industry-related experience, leadership experience, and publications/poster presentations/research preferred • Occasional travel as needed, less than 10%

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary BeOne Medicines Ltd. stock awards • Voluntary Employee Stock Purchase Plan participation • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid time off • Wellness program • Remote work arrangement • Occasional travel, less than 10%