Director, Regulatory Affairs – Dx/CDx, Medical Devices
BeOne Medicines
full-time
Posted on:
Location Type: Hybrid
Location: Basel • 🇨🇭 Switzerland
Visit company websiteJob Level
Lead
About the role
- Develop European and/or UK regulatory strategy for the designated program
- Contribute to clinical development plans to align diagnostic testing
- Act as representative of European regulatory team at global regulatory team for designated projects
- Drive strategy and oversee Dx/CDx and Device related content of regulatory documents
- Provide submission gap analyses, identify potential risks and propose solutions
- Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals
- Lead and mentor team members
- Maintain up-to-date knowledge of laws, regulations, and guidelines across European regulatory authorities
Requirements
- Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry with a bachelor's degree
- Minimum of 10 years’ experience in a Regulatory capacity with increasing responsibility
- Seasoned negotiator with a solid background in medical devices/diagnostic development regulations
- Experience working with Notified Bodies and various Member State HAs
- Sound understanding of the drug and diagnostic development process
- Recent experience with diagnostic testing to support clinical trials in all phases of study
- Proven ability to deliver on goals in a cross-functional environment
- English native speaker preferred
Benefits
- Equal opportunity employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentclinical development planningregulatory document oversightsubmission gap analysisrisk identification and solution proposalregulatory agency communicationmedical device regulationsdiagnostic development regulationsclinical trial supportcross-functional goal delivery
Soft skills
leadershipmentoringnegotiationcommunicationteam collaborationproblem-solvingadaptabilitystrategic thinkinginterpersonal skillsorganizational skills