Regulatory Affairs Manager

Regulatory Affairs Manager


Position Id:

Regulatory Affairs Manager

Looking for clinical regulatory generalist to support the company’s submissions efforts who is ready to take the next step in their career. S/he will be key in the preparation of documents and managing multiple IND/NDA applications and regulatory filings for phase I-III clinical trials. This is a high growth pharmaceutical opportunity, where you can make a significant impact.

The ideal professional will have:

  • Excellent writing skills- medical writing experience required
  • Minimum 4-5 years of related industry experience- has managed IND lifecycle: protocol amendments, DSUR, safety reports, briefing documents, etc.
  • Solid knowledge of FDA & ICH guidelines, GLP, GCP eCTDS (IND/NDA)
  • Excellent communication, collaboration and interpersonal skills
  • Strong Leadership and collaborative attitude
  • S./B.A required

My 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. It’s a great opportunity with excellent benefits, relocation, competitive compensation, and a terrific culture.

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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