Reference Number: JO-1906-432814
Head of Regulatory Affairs
Job Type: Permanent
Location: United States
Head of Regulatory Affairs required by a growing oncology biotech based in the New York City area. The company develops innovative medicines and other technologies to target and treat cancer.
Details of the role as follows:
• Develops regulatory strategies to expedite FDA review and approval of drug submissions in conjunction with EVP of Development
• Leads preparation and interactions (e.g., IND, pre-NDA/BLA, EOP2 meetings, advisory committee meetings, etc.) with the FDA and other foreign health authorities (e.g. Canada, EU) on behalf of all development programs and products
• Oversees regulatory operations, coordinates and directs the resources in preparation of and timely submissions to the FDA and other health authorities in support of development programs
• Maintains regulatory compliance for INDs, CTAs and NDAs/MAAs
• Cross-functionally partners with colleagues in to manage regulatory activities in preparation of submissions and translate regulatory requirements into pragmatic and strategic strategies and plans
• Plan, write, and review Health Authority document submissions (e.g. Briefing Documents)
• Develop and manage annual regulatory budget
• Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
Education: Advanced degree in Life Sciences, Ph.D. preferred
Experience: Candidates should have a minimum of 10-15 years of experience in pharmaceutical drug development as a regulatory lead.
For more information on this role and the company you will be working with please CLICK APPLY and forward an up to date resume.