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 a   Doctor of Pharmacy (PharmD) ,   M ater’s   in Regula tory   Affairs ,   or a   Ph . D .   in life sciences   by July 202 7 .

General Description:

The BeOne Medicines Global Regulatory Affairs (GRA) Fello w 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 202 7 .

**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)

- 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 analys e s of nuances of regulatory precedents along with tracking dynamic regulatory   environment   to support BeOne   pipeline p roducts .

- Using critical analysis, problem-solving and writing skills, the f ellow 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 promot e 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 implement ation   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   i nternal   c ross-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 strateg ies   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 Sm PC ) , the f ellow 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 u ses time efficiently   and c ompletes 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) .

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Travel:

On occasion, as needed   (l ess 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] .