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Regulatory Affairs Consultant


The remote Regulatory Affairs Consultant is responsible for creating regulatory strategies, leading global health agency filings, and managing FDA communications on behalf of the company's clients for devices and biopharmaceutical products. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities.

 

Responsibilities include:

  • Develop regulatory strategies for global submissions
  • Lead regulatory submissions: IND, IDE, NDA, BLA, PMA, 510k, etc. and their global counterparts including CE Marks.
  • Manage FDA and other global health authority face-face communications and via all other communication channels
  • Write regulatory documents – for paper and eSubmission
  • Lead cross functional teams across clinical, CMC, device engineering, quality, etc., in gathering and authoring required information for submission
  • Reports directly to Director of Quality/Regulatory

 

Training/Experience Requirements:

  • At least 10 years drug OR device regulatory experience.
  • RAC certification preferred
  • Bachelor’s degree required

 

Skills

  • Strong technical background required
  • Some experience in quality assurance roles or auditing preferred
  • Track record of leading regulatory strategy and filings for bio-pharma and/or device industry
  • Both drug and device experience a plus
  • Mix of large sponsor company and small startup experience a plus
  • Global filing experience preferred
  • Ability to work autonomously
  • Exceptional communication skills, both verbal and written

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