Global Regulatory Affairs Director

We have been engaged to find a Global Regulatory Affairs Director with expertise in Oncology to be located in either Cambridge, MA or Bridgewater, NJ. You will be responsible for leading the regulatory team on a global scale in the development of innovative and creative regulatory strategies for pipeline and lifecycle assets in the company’s growing and diversified oncology portfolio. 

Exciting new opportunity with a global leader in healthcare innovations, medicines and vaccines. Who Do You Know?

Global Regulatory Affairs Director qualifications include:

• Local to, or able to relocate to Cambridge, MA or Bridgewater, NJ (relocation plan is available)
• Bachelor’s Degree in relevant scientific discipline required, advanced degree is preferred (MS/MA/PharmD/Ph.D./ MD)
• RAPS or other certifications are a plus
• 8+ years in the pharmaceutical / biotech industry
• 6+ years of experience in regulatory affairs, oncology focus is preferred
• Proven experience with the preparation of BLA, NDA, MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional health authority
• Strong understanding of the clinical development of drugs and/or innovative biologics products is preferred
• Experience working in electronic document management systems such as Veeva Vault
• Knowledge and passion for the global oncology pharmaceutical and biologics industry with a focus on compliance and regulations

Industry: Pharmaceuticals, Biologics, Vaccines, Regulatory Affairs, Oncology

Job Code: j-34

Location: Cambridge, MA or Bridgewater, NJ