Director, Regulatory Affairs
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $176,000 - $236,000 per year
Job Level
Lead
About the role
- Develop, implement, and advise on NA regulatory strategies for development programs
- Manage NA regulatory aspects of compounds through all phases of development
- Interface with outside regulatory agencies and business partners
- Provide leadership and strategic regulatory oversight for projects
- Review sections of documentation for clinical trials and marketing applications
- Liaise and negotiate with the FDA and Health Canada
- Maintain awareness of global regulatory environment
- Train, develop, and manage an effective regional regulatory team
Requirements
- 10+ years of experience in the biotechnical or pharmaceutical industry
- 5+ years experience in a Regulatory capacity with a broad background
- Bachelor’s degree required; advanced degree preferred
- Experience working as a lead in Regulatory Affairs with the FDA
- Prior experience with both small molecules and biologics
- Thorough understanding of drug development process
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs
- Strong business acumen and ability to make sound decisions
- Excellent verbal and written skills
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 strategiesregulatory oversightclinical trials documentationmarketing applications documentationINDsCTAsNDAsBLAsdrug development processbiologics
Soft skills
leadershipstrategic thinkingnegotiationteam managementbusiness acumendecision makingverbal communicationwritten communication