Regulatory Affairs Director – Biotech – Home Based

Apsida
Location: United States
Salary: Competitive

Apsida Life Science are currently partnered with a commercial-stage biotechnology company who are a leader in developing and commercializing novel cancer therapies.

 

The organisation have had a number of successes across their portfolio, including a number of product approvals globally.

 

The biotech are currently expanding the Regulatory Affairs team by appointing a  new Senior Regulatory Affairs Director. The individual will be responsible for the development and implementation of regulatory strategies for projects, whilst being the regulatory lead on the respective program teams.

 

The role reports to the Vice President, Regulatory Affairs:

 

Responsibilities:

  • Responsible for the regulatory portfolio assigned, from strategy development and implementation to execution of submissions for all stages of development
  • Provide regulatory leadership and guidance to assigned program teams
  • Develop and mentor junior Regulatory staff members
  • Develop briefing packages and regulatory applications (e.g. orphan, pediatrics, etc.) to the FDA and other global health authorities
  • Responsible for regulatory compliance with pre and post approval filings
  • Develop response and submission strategies to regulatory information requests in close collaboration with other team members
  • Lead submission teams to successful filing and approval of all types of submission packages
  • Contribute to regulatory intelligence, regulatory science, and regulatory policy
  • Participate and contribute to Health Authority meetings

 

Requirements:

  • Minimum B.S. degree in a life science related field
  • Minimum of 8 years of regulatory experience within the biotech or pharmaceutical industry
  • A minimum of 5 year’s experience within the regulatory drug development and approval process in IND/CTAs/Marketing Applications
  • Experience preparing NDAs/MAAs
  • Experience in communicating with relevant regulatory authorities

 

For further info get in touch!

The Consultant

Ethan Cortese

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