Associate Director, Regulatory Affairs – Oncology
Sumitomo Pharma America, Inc.
Director, Regulatory Affairs, Dx/CDx, Medical Devices
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $171,300 - $231,300 per year
Job Level
Lead
About the role
- Lead a small team for developing and implementing regulatory diagnostic and medical device strategies
- Develop European and/or UK regulatory strategy for the designated program
- Act as the representative of European regulatory team at the global regulatory team (GRT)
- Provide direction and oversight for Dx/CDx and Device related content of regulatory documents
- Identify potential risks and propose solutions/mitigation plans for successful acceptance of submissions
- Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals
- Maintain up-to-date working knowledge of laws, regulations, and guidelines
- Represent the BeOne European regulatory function at industry consortium
Requirements
- Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry
- Bachelor's degree
- Minimum of 10 years’ experience in a Regulatory capacity with increasing responsibility
- Strong background in medical devices/diagnostic development regulations
- Experience working with Notified Bodies and various Member State HAs
- Recent experience with diagnostic testing to support clinical trials
- Proven ability to deliver on goals within a cross-functional team environment
- English native speaker preferred
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory documentssubmissionsmedical device regulationsdiagnostic development regulationsrisk identificationmitigation plansregulatory agency communicationsclinical trialscross-functional team collaboration
Soft skills
leadershipcommunicationdirectionoversightproblem-solvinggoal deliveryteamworkadaptabilityrepresentationinterpersonal skills
Certifications
Bachelor's degree
