BeOne Medicines
Cancer has no borders. Neither do we.
Director, Global Regulatory Lead
Location
United States
Posted
44 days ago
Salary
$176K - $236K / year
Seniority
Senior
Bachelor Degree10 yrs expEnglish
Job Description
• Develop, implement, and advise on global regulatory strategies for product(s)
• Manage regulatory aspects of compounds through all phases of development
• Provide leadership and regulatory oversight for designated projects
• Interface with business partners regarding regulatory and registration strategies
• Support preparation and submission of regulatory documentation
Job 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 understanding of drug development process and healthcare environment
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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