Quality Recruiting. Established Experts.

Associate Director, Regulatory Strategy

Reference Number: 4179
Location: MA

Our client is a global biopharmaceutical company. They have asked us to assist them in their search for an Associate Director, Regulatory Strategy.

Major tasks and responsibilities will include:

  • Assumes the role of Global Regulatory Lead (GRL) for assigned products.
  • Leads the planning, execution and assessment of product life cycle management activities from early development through post-approval.
  • Proactively formulates regulatory strategies that provide for streamlined development and approval timelines, while accurately interpreting and reflecting regulatory and Corporate guidelines.
  • Leads the planning, preparation for and conduct of meetings with Health Authorities for all assigned products.
  • Initiates and responds to Health Authority contacts to ensure expedient and efficient review and approval of products.
  • Leads the creation of, and submission of, all documents submitted to Health Authorities have been evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance as well as presented in a way that facilitates review.
  • Identifies, monitors and resolves regulatory issues; and reports progress to management.
  • Guides project teams to implement appropriate regulatory strategies.
  • Serves as Chair of the Global Regulatory Sub-team.
  • Leads the assessment of regulatory support needs and aligns resources.
  • Leads and coordinates all regulatory activities required for submissions to Health Authorities for assigned products.
  • Approximately 10% travel based on business needs.
  • This role has the potential to manage a direct report based on business needs.

We seek candidates with the following qualifications:

  • Bachelor’s degree in the sciences or health related field required. Advanced degree highly preferred
  • Must have a minimum of 6 years of pharmaceutical industry experience in Regulatory Strategy.
  • Requires knowledge of US and global regulations and specific Health Authority guidance documents.
  • Experience with preparing IND/CTA submissions and briefing packages for Healthy Authority meetings required.
  • Experience with successful NDA, sNDA and/or BLA filings highly preferred.
  • Experience working with the global Health Authorities highly preferred.

If interested, please email your resume as a Word attachment to us, reference 4179.  No calls or faxes, 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.