Director, Regulatory Affairs
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Job Description
Director of Regulatory Affairs responsible for NA regulatory strategies in oncology product development. Leading regulatory oversight to ensure compliance with FDA and Health Canada regulations.
Responsibilities:
- 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
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