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Regulatory Operations Manager

  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: Negotiable
  • Job reference: 328961/001_1560541016
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/06/2019

Regulatory Operations Manager

My client is looking for a Regulatory Operations Manager on a permanent full-time basis. The Regulatory Operations Manager will be responsible for processing, publishing, contributing to, and managing the regulatory submissions process.

My client is a growing pharma company with various locations across the US. With an approved drug last and a strong current pipeline, now is an exciting time to enter the company.

Responsibilities

  • Publish compliant documents (eCTD)

  • Manage submission lifecycles (IND and NDA)

  • Schedule/track eCTD submissions

  • Write/maintain SOPs

Requirements

  • Bachelor's degree in a life science related field (Master's preferred)

  • 5+ years of regulatory operations experience in the pharma/biotech industry

  • Hands on experience with different electronic submission software

Apply now!

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