Global Regulatory Affairs Fellow

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in a comprehensive one-year rotational program encompassing Global Regulatory Policy and Intelligence, Regulatory Strategy, Advertising and Promotion, and Labeling.

• Evaluate regulatory trends from health authorities, policy initiatives, approvals, precedents, and the evolving regulatory landscape.

• Develop regulatory background packages, competitive benchmarking summaries, regulatory strategy inquiries, and analyses of regulatory topics.

• Design and deliver presentations on regulatory topics at internal forums.

• Identify and promote potential candidates for future GRA fellowships.

• Assist in the formulation and execution of regulatory strategies for the BeOne pipeline drug development initiatives.

• Examine regulatory environments and tackle regulatory challenges utilizing GRPI outputs.

• Facilitate communications with health authorities, including new INDs, submission cover letters, and NDAs/BLAs.

• Implement FDA regulatory requirements in promotional and product-related communications.

• Participate in internal cross-functional Promotional Review Committee meetings.

• Review promotional materials under supervision for new product launches or new indications.

• Contribute to the global and local product-labeling strategy, operations, management, and governance.

• Monitor developments such as new indications and safety issues, updating or maintaining global and local product labeling and the Company Core Data Sheet.

• Conduct labeling comparisons for potential new product launches or new indications using USPI and SmPC labels.

• Collaborate closely with Global Regulatory Affairs in a matrix team; this position does not have direct reports.

⛳️ Requirements

• Candidates must have completed a Doctor of Pharmacy (PharmD), a Master’s in Regulatory Affairs, or a Ph.D. in life sciences by July 2027.

• Strong analytical, problem-solving, and critical-thinking abilities.

• Excellent written and verbal communication skills.

• Project management expertise; capable of prioritizing tasks, managing time effectively, and ensuring accuracy in task completion.

• Adaptability to evolving regulations, shifting priorities, and uncertainty.

• Ability to innovatively navigate regulatory limitations and propose creative solutions.

• Proficient in Excel, PowerPoint, Word, and electronic document management systems, such as Veeva.

• Submission of CV, letter of intent, and unofficial college transcript is required during the application process.

• Preferred qualifications include professional work experience, industry-related experience, leadership roles, and publications or presentations.

• Occasional travel required, less than 10%.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Participation in an incentive compensation plan for commercial roles.

• Discretionary stock awards from BeOne Medicines Ltd.

• Opportunity to participate in a Voluntary Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance assistance.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.

• Life insurance benefits.

• Paid time off for employees.

• Access to a wellness program.

• Remote work arrangement available.

• Occasional travel required, less than 10%.