Regulatory Affairs Specialist

Regulatory Affairs Specialist


Position Id:

Regulatory Affairs Specialist – Great Growth Company

Our client is in need of a clinical regulatory affairs specialist who can support the Company’s submissions efforts. S/he will be key in the preparation of submission documents while managing multiple applications and regulatory filings for phase I-III clinical trials.

This is a high growth pharmaceutical opportunity, where you can make a significant impact and grow your career.

The ideal professional will have:

  • Excellent writing skills: some medical writing experience coupled with acute attention to detail
  • Minimum 3 years of relevant experience in a regulated industry – pharma or med device
  • Knowledge of FDA & ICH guidelines, GLP, GCP, eCTDS (IND/NDA)
  • Strong communication skills and collaborative attitude
  • Bachelor’s degree required

This a great opportunity that offers excellent benefits, relocation, competitive compensation, and a terrific company culture.

My southeast client is highly motivated to fill this critical position as soon as possible. If you meet the above criteria, please send me your resume today. We will set up a time to discuss your experience, goals, and if this position is a fit for you.

Keywords: IND, CTA, NDA, regulatory, protocol amendments, clinical/preclinical information amendments, annual reports, DSUR’s, expedited safety reports, health authorities, FDA, Health Canada, regulatory agencies, clinical trials, Investigational New Drug Application, US New Drug Application, CTD, GLP, GCP, GMP

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