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Job Details

Regulatory Affairs Associate - Contract

Company: EPM Scientific
Location: New York
Reference: AC/NY/regaffairs
Closing Date: 03 Jul 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Regulatory Affairs Associate – Contract***REMOTE POSITION***My client is looking for a Regulatory Affairs Associate to join the team for 3-6 months. The Regulatory...

Requirements:

Regulatory Affairs Associate – Contract

***REMOTE POSITION***

My client is looking for a Regulatory Affairs Associate to join the team for 3-6 months. The Regulatory Affairs Associate will be responsible for preparing, reviewing, and submitting high-quality regulatory submissions to the FDA within a set time frame.

My client is a regulatory consulting firm that provides regulatory expertise to well-known pharmaceutical/biotechnology clients throughout the US.

Responsibilities

  • Prepare/review regulatory submissions (supplements, annual reports, etc.) for FDA submissions
  • Evaluate/look over changes to regulatory documents and provide opinion on changes
  • Work closely with regulatory team to obtain all of the required documentation for submissions

 
Requirements

  • Bachelor’s in a life sciences related field (Master’s preferred)
  • 3+ years of relevant experience in the pharmaceutical industry
  • Post approval regulatory experience in generics required
  • Good working knowledge of CMC as needed for NDA and ANDA submissions


Apply now! 



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