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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