Director, Global Regulatory Lead
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $176,000 - $236,000 per year
Job Level
About the role
- Develop and implement global regulatory strategies for development programs
- Manage regulatory aspects of compounds through all phases of development
- Provide leadership and strategic regulatory oversight for designated projects
- Interface with business partners regarding global development, regulatory, and registration strategies
- Support preparation and submission of global regulatory documentation
Requirements
- BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry
- 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge
- Experience working as a lead in Regulatory Affairs across two or more major geographic areas
- Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
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 & Tools
regulatory strategiesregulatory oversightglobal regulatory documentationINDsCTAsNDAsBLAsMAAs
Soft Skills
leadershipstrategic thinkingbusiness acumendecision making
Certifications
BSMSPhDMDPharmD