Director, Regulatory Affairs

Our client is a science-driven biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs.

Major tasks and responsibilities will include:
  • Provides regulatory expertise and guidance within a cross-functional team.
  • Advises and oversees internal personnel regarding the development and implementation of regulatory strategy.
  • Supports the preparation of, and participates in (as appropriate), key Health Authority interactions.
  • Assures consistent positions on common issues are presented to global Health Authorities.
  • Leads the development and timely completion of Health Authority background documents and responses to queries from Health Authorities.
  • Provides regulatory expertise to support Clinical Study teams.
  • Offers strategic guidance on development documents, clinical protocols, study reports, IBs, INDs, and CTAs.
  • Develops content and format for regulatory submissions.
  • Maintains excellent relationships with regulatory agency personnel.
  • Responds to requests for additional data.
  • Organizes and manages participation in meetings.
  • Negotiates directly with regulatory authorities regarding company’s filings.
  • Collaborates cross-functionally to develop and implement revised/new labeling strategies.
  • Collaborates with Regulatory AdPromo and Labeling, Operations and CMC to ensure an aligned approach to regulatory strategy.
  • Maintains global regulatory strategy documentation for assigned projects.
  • Interprets scientific and clinical data.
  • Leads the development of labeling to optimize product potential and patient benefit-risk ratio.
  • Mentors and trains junior regulatory staff.
We seek candidates with the following qualifications:
  • Bachelor’s degree required. Master’s degree or PhD preferred.
  • Must have a minimum of 10 years of related experience within the biotechnology/pharmaceutical industry
  • Must have a minimum of 8 years of clinical regulatory experience or equivalent combination of education and experience.
  • Successful completion of an NDA and MAA application(s) required.
  • Requires strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus.
  • Must have solid understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process.
  • Working knowledge of eCTD submissions and supportive technologies required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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