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Head of Global Regulatory Affairs

2 months ago

Boston, Massachusetts, United States Planet Pharma Full time

Exciting Opportunity:

Join Planet Pharma, a pioneering organization in the pharmaceutical sector, where we unite diverse talents to foster innovative solutions in healthcare. We are looking for a Director of Global Regulatory Strategy to spearhead regulatory initiatives for our distinctive and intricate products designed to treat rare diseases and fulfill critical medical needs. If you possess strategic insight and a commitment to enhancing patient outcomes, we invite you to explore this opportunity.

Key Responsibilities:

  • Formulate and execute global and/or US regulatory frameworks for effective product approval and lifecycle management.
  • Oversee regulatory strategies for specific initiatives and across the company's diverse portfolio.
  • Serve as the primary liaison with regulatory authorities and represent the organization in key meetings.
  • Provide expert regulatory counsel to internal teams and foster cross-departmental collaboration.
  • Lead US submissions for development initiatives while ensuring adherence to regulatory standards.
  • Stay informed on emerging regulatory trends and assess their implications for business operations.

Qualifications:

  • Bachelor's Degree in a relevant field.
  • 5-7 years of experience in US pharmaceutical development and regulatory affairs.
  • Proven track record in leading significant submissions and engaging with regulatory bodies.
  • Excellent interpersonal and communication capabilities.
  • Strong analytical skills and sound judgment in risk evaluation.
  • Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).