Senior Director, Regulatory Affairs

1 week ago

Redwood City, California, United States Corcept Therapeutics Full time
Job Summary

Corcept Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities, including delineating regulatory strategies for commercial and corporate communications, providing strategic input on campaigns and product strategy, and managing the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assets.

Key Responsibilities
  • Regulatory Strategy: Develop and implement regulatory strategies for commercial and corporate communications, ensuring compliance with domestic and foreign legislation.
  • Campaign and Product Strategy: Provide strategic input on campaigns and product strategy, ensuring alignment with regulatory requirements.
  • Regulatory Labeling: Manage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assets.
  • Regulatory Submissions: Lead the development of regulatory submissions of promotional materials for marketed products.
  • Regulatory Risk Management: Identify and mitigate regulatory risks associated with commercial and corporate communications.
  • Vendor Management: Manage external regulatory vendors and service providers.
  • Regulatory Agency Relations: Build relationships with regulatory agencies and represent the company in key meetings.
  • Regulatory Compliance: Review and approve product labeling, promotional claims, and advertising to ensure regulatory compliance.
Requirements
  • Experience: 12+ years of Regulatory Ad/Promo experience, with a strong understanding of US FDA regulations and international regulatory agencies.
  • Education: BA/BS Degree in health/life sciences or related field, with an advanced degree (PharmD, PhD, MS) highly preferred.

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