Regulatory Affairs Director, Dx/CDx and Medical Devices, US

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.

General Description:

The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies, for the designated program(s) to support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, and in coordination with key internal and external stakeholders.

Essential Functions of the job:

• Develop US regulatory strategy for the designated program(s) and contribute to the clinical development plans to align diagnostic testing and drive integration to therapeutic development plans.

• Act as the representative of the US regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams on specific programs or for specific topics

• Drive the strategy, providing direction and oversight for Dx/CDx and Device related content of regulatory documents, such as assessments, regulatory memos, and briefing documents and responses, for interactions with US regulatory authorities, as applicable.

• Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of diagnostic submissions

• Oversee and be accountable for Dx/CDx and Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review

• Lead and mentor team members

• Maintain up-to-date working knowledge of laws, regulations, and guidelines applicable to the US testing space.

• Represent BeOne’s US Dx/CDx and MedDev regulatory function at industry consortium (may be required).

Other Qualifications:

• Minimum BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience, or 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with increasing responsibility.

• Seasoned negotiator, both internally and externally with a solid background in medical devices/diagnostic development regulations and associated regulatory deliverables.

• Experience working with various Health Authorities, primarily FDA, to support diagnostic testing.

• Sound understanding of the drug and diagnostic development process, the pharmaceutical industry and healthcare environment including Global and US regulatory requirements and policy trends

• Recent experience with diagnostic testing to support clinical trials in all phases of study, is mandatory for this role.

• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

• English native speaker is preferred

• Location: US (remote).
   

Reports To: Executive Director, Global Regulatory Strategy, Dx/CDx and Medical Devices.

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

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 accommodationsus@beonemed.com.