Director, Regulatory Affairs, Dx/CDx and Medical Devices

Role Summary

Director, Regulatory Affairs, Dx/CDx and Medical Devices is responsible for leading a small team to develop and implement regulatory strategies for diagnostics and medical devices, support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, coordinating with internal and external stakeholders.

Responsibilities

• 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 designated projects needing diagnostics, and may 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

• Minimum of 10+ years‚Äô experience in the biotechnical or pharmaceutical industry with a bachelor's degree, and a minimum of 10 years‚Äô experience in a Regulatory capacity with increasing responsibility.
• Seasoned negotiator, with a solid background in medical devices/diagnostic development regulations and associated regulatory deliverables.
• Experience working with Notified Bodies and various Member State HAs to support diagnostic testing.
• Sound understanding of the drug and diagnostic development process, the pharmaceutical industry and healthcare environment including Global and EU/UK 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 and remote working possible.

Location

Remote

Reports To

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

Skills

• Regulatory strategy development
• Regulatory submissions and communications
• Cross-functional collaboration
• Risk assessment and mitigation
• Mentorship and leadership
• Knowledge of EU/UK regulatory requirements and partner engagement with Notified Bodies