Associate Director, Regulatory Affairs

San Diego - California - United States - Life Sciences & Health Care - Biotechnology - Regulatory - Academic Bachelor

Looking for an Associate Director of Regulatory Affairs to work in house at a small biotech in Torrey Pines.

Feel free to contact

Daniel Hennelly, Account manager

Apply now

About this role

Work on cross-functional teams including product development, quality, manufacturing to ensure regulatory strategy and requirements are uniformly linked. Responsible for submission and approval of regulatory filings.

About you

  • Bachelors degree in a life science and a minimum of 7 years of regulatory affairs experience within a pharmaceutical or biotech company
  • Experienced in EMA/FDA regulators, regulations and approval process
  • Experience in IND, NDA/BLA, annual reports, amendments, and MAAs;
  • European and/or global submissions experience in a small biotech company is a plus;
  • RAC certified is ideal.

Summary

  • Vacancy number: PUB185129
  • Location: San Diego
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Biotechnology
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Friday, December 21, 2018
Apply now

Feel free to contact

DH

Daniel Hennelly

Account manager Brunel Energy USA Houston

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