Director of Regulatory Affairs

Posted 17 March 2020
Salary Up to US$0.00 per annum
LocationCambridge
Job type Permanent
ReferenceBBBH92197_1584458629
Contact NameBria Gaber

Job description

Senior Director, Regulatory Affairs

Massachusetts - United States


Seeking an experienced Global Regulatory Affairs Director to lead the regulatory submissions process to ensure all submissions meet full compliance with all relevant requirements.

Qualifications:

  • Bachelors degree in relevant scientific discipline; Masters or advanced degree PhD, PharmD is preferred
  • Minimum of 10 years of regulatory affairs experience in the pharmaceutical and/or biotech industry
  • Recent filing experience (INDs and NDAs) in leading all negotiations and health authority interactions
  • Experience leading a team in the development of clinical regulatory documents, ie: INDs, CTAs, BLAs, DMFs, NDAs and MAAs
  • Strong understanding and knowledge of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements
  • Experience taking drugs to the next level (from phase I to III)
  • Small molecules + Large molecules experience
  • drug + device (companion diagnostics)
  • US regulatory and global experience in EU, Japan, Canada & Australia
  • Oncology therapeutic experience is preferred