Director, Regulatory Affairs, Dx / CDx and Medical Devices

Director, Regulatory Affairs, Dx / CDx and Medical Devices

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.

Job Description

The Director, Regulatory Affairs, Dx / CDx and Medical Devices will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for the designated program 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 European and / or UK regulatory strategy for the designated program, and contribute to the clinical development plans to align diagnostic testing and drive integration to therapeutic development plans.
• Act as the representative of the European 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 for specific topics.
• Drive the strategy, providing direction and oversight for Dx / CDx and Device related content of regulatory documents, such as, CPS, CPSR, IBs, and briefing documents for interactions with European regulatory authorities or RFIs, 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 across the European regulatory authorities and the UK.
• Represent the BeOne European regulatory function at industry consortium (may be required).

Qualifications

Location : Remote or office in Switzerland

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

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.