[Hiring] Global Regulatory Affairs Fellow @BeiGene

Role Description

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.

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
• Labeling

The Fellow will apply their scientific knowledge, regulatory learnings, and independent judgment to support and execute key deliverables for each sub-function. Effective communication, both written and verbal, and critical thinking are vital skills for 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 the four below sub-departments and perform the tasks identified below under the supervision of each respective sub-department:

Global Regulatory Policy and Intelligence (GRPI)

• Analyze and present the latest in health authority regulatory trends, policy initiatives, and approvals across therapeutic areas.
• Complete timely and thorough analyses of nuances of regulatory precedents.
• Track dynamic regulatory environment to support BeOne pipeline products.
• Work on GRPI deliverables (e.g., regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses).
• 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.

Global Regulatory Affairs - Strategy

• Plan and coordinate regulatory submissions and provide guidance to the cross-functional development teams on regulatory strategy and tactics.
• Partner closely with the regulatory affairs strategy lead(s) to support 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.

Global Regulatory Affairs - Advertising and Promotion

• Administer the promotional review process and prepare FDA submissions for promotional materials.
• Provide regulatory review and oversight for promotional and non-promotional product communications.
• Apply FDA regulatory requirements for promotion and other product-related communications.
• 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.

Global Regulatory Affairs - Labeling

• Develop and maintain global core labeling for commercial products.
• Provide regulatory support for local labeling development and implementation.
• 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.

Qualifications

• Doctor of Pharmacy (PharmD), Master’s in Regulatory Affairs, or Ph.D. in life sciences by July 2027.
• Professional work experience.
• Industry related experience.
• Leadership experience.
• Publications / Poster Presentations/Research.

Requirements

• Strong problem-solving skills to interpret complex regulations and develop strategies.
• Clear written and verbal communication skills for drafting regulatory documents and liaising with regulatory authorities.
• Ability to prioritize work activities and complete tasks accurately.
• Adaptability to stay updated on changing regulations and manage shifting priorities.
• Innovation in navigating regulatory constraints and proposing forward-thinking solutions.
• Advanced application capability with Excel, PowerPoint, Word, and electronic document management systems (i.e., Veeva).

Benefits

• Medical, Dental, Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

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.

In order to ensure reasonable accommodation for individuals protected by applicable laws, applicants who require reasonable accommodation in the job application process may contact [email protected].