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Open nowFirst seen 5 days ago

Global Regulatory Affairs (GRA) Fellow

Lifelancer3,750 open roles

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Your applicationOpen nowGlobal Regulatory Affairs (GRA) FellowLifelancer · Remote

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This job: first seen 5 days ago

The posting

Job Title: Global Regulatory Affairs (GRA) Fellow

Job Location: Remote (US)

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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.

** When applying, please upload your curriculum vitae (CV), letter of intent, and unofficial college transcript in PDF format under the "CV/Resume" section of the application.

Education Required:

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

General Description:

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, and Labeling. The Fellow will apply their scientific knowledge, regulatory learnings and independent judgment to support and execute key deliverables for each sub-function. These key deliverables, presentations and projects inform important regulatory strategy. Effective communication, both written and verbal, and critical thinking are vital skills for this role. The fellowship will be conducted remotely beginning July 2027.

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)

  • The GRPI team analyzes and presents the latest in health authority regulatory trends, policy initiatives, and approvals across therapeutic areas.
  • The fellow will complete timely and thorough analyses of nuances of regulatory precedents along with tracking dynamic regulatory environment to support BeOne pipeline products.
  • Using critical analysis, problem-solving and writing skills, the fellow will work on GRPI deliverables (examples are regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses, etc.).
  • Fellow will create presentations and present on relevant regulatory topics at internal forums.
  • Fellow will recruit and promote for potential future GRA fellowship recruitment cycle during their fellowship year.

Global Regulatory Affairs - Strategy

  • The regulatory strategy team plans and coordinates regulatory submissions and provides guidance to the cross-functional development teams on regulatory strategy and tactics.
  • The fellow will partner closely with the regulatory affairs strategy lead(s) by supporting the development and implementation strategies for optimal regulatory development of BeOne pipeline drug development programs.
  • Fellow will utilize GRPI deliverables to assess regulatory landscape to address regulatory challenges.
  • Fellow may 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

  • 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.
  • The fellow will apply FDA regulatory requirements for promotion and other product related communications.
  • Fellow will actively participate in internal cross-functional Promotional Review Committee (PRC) Meetings.
  • Fellow will review promotional materials under supervision of regulatory advertisement and promotion staff member for new products and/or new indication launches.

​

Global Regulatory Affairs - Labeling

  • The labeling team develops and maintains global core labeling for commercial products and provides regulatory support for local labeling development and implementation.
  • The fellow will apply regulatory labeling strategies and operations, and support activities for management and governance of global and local product labeling.
  • Fellow will 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).
  • Analyzing labels (USPI and SmPC), the fellow will conduct labeling comparisons of potential new product and/or new indication launches.

Supervisory Responsibilities:

  • The position has no direct reports. The Fellow is part of a team that performs high quality and timely regulatory analyses. This position works closely with GRA as part of a matrix team.

Preferred Qualifications:

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

Other Qualifications:

  • Analytical and Critical Thinking: Strong problem-solving skills are essential to interpret complex regulations, assess their impact on organizational processes, and develop strategies to meet evolving regulatory demands.
  • Written and Verbal Communication Skills: Clear written and verbal communication is critical for drafting regulatory documents, explaining requirements to stakeholders, and liaising with regulatory authorities.
  • Project Management: Prioritizes work activities and uses time efficiently and completes tasks accurately. Follows instructions and responds to management direction.
  • Adaptability: The ability to stay updated on changing regulations, manage shifting priorities, and navigate ambiguity is vital in dynamic regulatory environments.
  • Innovation: The ability to creatively navigate regulatory constraints and propose forward-thinking solutions, such as leveraging emerging technologies or streamlining processes.

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

​

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 protected].

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

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