Regulatory Affairs Director

1 week ago

Rochester, Minnesota, United States Sterling Life Sciences Full time
Job Title: Associate Director of Regulatory Affairs

At Sterling Life Sciences, we are seeking an experienced Associate Director of Regulatory Affairs to join our team. This is a key role that will play a critical part in ensuring the success of our gene therapy programs.

Key Responsibilities:
  • Provide regulatory guidance and strategy for gene therapy programs, including assessing and identifying regulatory risks.
  • Manage activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA and other regulatory authorities.
  • Review and provide input on all regulatory filing documents.
  • Lead and facilitate activities, including team preparation, for meetings with FDA and other regulatory authorities for development activities.
  • Be responsible for communicating with FDA and other regulatory authorities.
  • Identify issues and develop appropriate regulatory strategies to mitigate risks to filings.
  • Ensure stakeholders are informed of developments that may affect regulatory success.
  • Perform compliance functions within the company.
  • Coordinate and manage regulatory inspections, as needed.
  • Stay current with emerging legislation and guidance in the field and contribute to ensuring company-level awareness and compliance.
Critical Requirements:
  • A university degree is required. Preference will be given to those with degrees in a relevant field.
  • Appropriate full-time work experience is mandatory (no students or fresh graduates please).
  • Recent experience in the biotechnology industry is strongly preferred.
  • Preference will be given to candidates with recent experience in regulatory affairs management.

This is a highly competitive role with a highly competitive package, commensurate with experience. If you are a motivated and experienced professional looking for a new challenge, please apply with your resume and cover letter.

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