Global Regulatory Affairs Director

TWG Recruiters 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
  • Prior biologics and/or vaccines regulatory oversight and product development strategy is a plus for this role

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

Job Code: j-166

Location: Cambridge, MA or Bridgewater, NJ 

Apply directly at: Global Regulatory Affairs Director

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TWG Recruiters has a strict policy of promotion and insuring of equal opportunity for all persons, without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, employed or seeking employment. We follow EEOC and OFCCP guidelines. 

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