Remote Regulatory Affairs Process Expert

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Oct 08, 2021

This job expires in: 12 days

Job Category: Business Operations

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

An analytical laboratory instrument manufacturing company has a current position open for a Remote Regulatory Affairs Process Expert.

Core Responsibilities of this position include:

  • Guiding the customer in preparing data sets for new process filings and post-approval changes
  • Acting as a Subject Matter Expert on validation strategies to introduce new technologies
  • Acting as an internal liaison to compile complex data packages to support process optimizations

Required Skills:

  • A minimum of 8 years’ experience in Quality or Regulatory affairs within the biopharmaceutical industry
  • Bachelor's degree or higher in biotechnology, biochemistry, chemical engineering or equivalent
  • Proven working knowledge of cGMP Quality and Regulatory requirements essential
  • Fully conversant in the FDA, EMA and ICH regulatory requirements
  • Detailed working knowledge of pharmaceutical validation processes and regulatory approval process
  • Detailed working knowledge of US and European Pharmacopeia requirements as well as ISO guidances

COMPLETE JOB DESCRIPTION

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