Director of Regulatory Affairs

  • Location: Newark, Delaware
  • Remote: Remote
  • Type: Direct Hire
  • Job #17497

Director of Regulatory Affairs
Location: Fully Remote with no travel to any office.

Scientific Search has partnered with a biopharmaceutical company that is expanding rapidly and searching for a Director for Global Regulatory Affairs to help create and manage the regulatory submissions in the US, Australia, and Europe.  This position will work on biologic pipeline assets in immunotherapy of oncological diseases.

Responsibilities
 

  • Along with CRO, design and draft the regulatory documents such as cover letters, meeting minutes, background package for Pre-IND, guide company staff in writing of the summary modules for the IND/CTD, and other required regulatory documents.
  • Engage with key Health Authorities to enable successful regulatory filings and manage ongoing meetings and communications.
  • Coordinate regulatory activities internally across the portfolio as well as externally with consultants and biotech/pharma partners.
  • Coordinate efforts across a global Regulatory Affairs team in the U.S. and other countries, sans China.
  • Keep abreast of global regulatory changes and inform the company of potential impact on development programs.

Requirements

  • Professional degree in biomedical sciences and clinical medicine, such as pharmacy, biology, immunology.
  • Excellent oral and written communication skills with successful presentation capabilities.
  • Experience in regulatory activities in a biotech/pharmaceutical company, CRO or Health Agency.
  • Experience in team management and coordination.
  • Scientific knowledge in immunology and/or oncology preferred.

Be sure to check out all of our other current openings at www.scientificsearch.com

For immediate consideration please email Jelena Kocovic, at Jelena@Scientificsearch.com

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