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Head of Regulatory Affairs

Reference Number: 2827
Location: Remote-Based

Our client is a clinical stage biopharmaceutical company.  They have asked us to assist them in their search for a Head of Regulatory Affairs.

The HHHHHhhhhead of Regulatory Affairs will be a key member of the leadership team, reporting to the Executive Vice President, R&D and COO.  The individual will become a key interface with FDA and other regulatory authorities as well as a key internal advisor.

Major tasks and responsibilities will include:

  • Provides counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines.
  • Assists as a liaison between the company and regulatory authorities.
  • Interprets, plans, and communicates requirements to ensure FDA approvals are obtained.
  • Represent the company before regulatory authorities.
  • Responsible for filing of IND/NDA submissions.
  • Interacts with other functions in the preparation, review, and completion of documents for regulatory submissions.
  • Responsible for keeping the Executive Leadership Team and the Development Team informed of regulatory status and significant regulatory issues, and is able to present and implement project related regulatory strategy with all Project Teams.
  • Assures compliance with project team timelines and milestones.
  • Effectively plans, organizes, and conducts formal meetings with regulatory agencies.  Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of studies.
  • Responsible for building and maintaining key external relationships across regulatory agencies and key stake holders.
  • Responsible for cultivating a high achievement regulatory team focused on accountability and meeting and exceeding expectations.

We seek candidates with the following qualifications:

  • BS, MS, or Ph.D. in a Life Sciences discipline or equivalent.
  • Minimum of 15 years of experience in regulatory and at least 10 years of progressive leadership experience in the Pharmaceutical or Biotechnology industry.
  • Strong understanding of the drug development process.
  • Familiarity with cardiovascular and/or lipid regulating drug development and regulatory requirements in major markets.
  • Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
  • Experience with US, EU and global regulatory activities including product registrations, IND, NDA and MAA filings, and safety reporting.
  • Experienced team player with strong management and interpersonal skills to quickly gain confidence both with internal stakeholders and externally among regulatory agencies.
  • Ability to influence direction of complex regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
  • Technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, business development, legal, etc.).

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2827. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.