Director, Global Regulatory Affairs

New Jersey
4465
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Global Regulatory Affairs.  

Major tasks and responsibilities will include:
  • Develops and implements novel drug regulatory strategy.
  • Ensures the company’s development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
  • Has strong project management skills and strong interpersonal skills to handle complex distributed programs.
  • Authors straightforward regulatory documents with oversight of all documents for regulatory submissions and associated messaging.
  • Ensures overall regulatory strategy and regulatory CMC strategy are aligned by working closely with regulatory CMC lead and overall development team.
  • Acts as the point of contact between the company and the regulatory agency – serves as the regulatory liaison for the company.

We seek candidates with the following qualifications:
  • Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering or Chemical Engineering is required. PhD or PharmD are preferred.
  • Must have CMC and/or Botanical experience and RAC certification.
  • Requires thorough understanding of ICH and US CFR requirements and regulations.
  • Regulatory document submissions authoring experience is required.
  • Must have experience with direct interaction with regulatory agencies.
  • Requires strong communications skills.

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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