Senior Director Regulatory Affairs

4 weeks ago

Redwood City, California, United States Corcept Therapeutics Full time
Job Title: Senior Director Regulatory Affairs

Corcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to join our team and support the commercialization of our late-stage programs.

Key Responsibilities:
  • Develop and implement regulatory strategies for commercial and corporate communications, ensuring compliance with domestic and foreign legislation.
  • Provide strategic input on campaigns and product strategy, ensuring alignment with regulatory requirements.
  • Manage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assets.
  • Lead the development of regulatory submissions of promotional materials for marketed products.
  • Define and advance regulatory strategies for product registration and commercialization.
  • Review and approve product labeling, promotional claims, and advertising to ensure regulatory compliance.
  • Identify and mitigate regulatory risks, ensuring the company's regulatory posture is strong and proactive.
  • Manage external regulatory vendors and service providers, ensuring high-quality services and cost-effectiveness.
  • Build relationships with regulatory agencies and represent the company in key meetings, ensuring effective communication and collaboration.
  • Review non-promotional materials for regulatory compliance, ensuring all company communications are compliant with regulatory requirements.
  • Generate regulatory TPPs and draft labeling for pipeline molecules, ensuring accurate and compliant documentation.
  • Support regulatory inspections and approval strategies for global markets, ensuring seamless regulatory processes.
Requirements:
  • 12+ years of experience in Regulatory Affairs, with a strong background in commercial regulatory strategy and labeling.
  • Experience leading interactions with health authorities (US and ex-US) and understanding of US FDA regulations and international regulatory agencies.
  • Regulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategies.
  • Excellent project management, negotiating, and communication skills, with the ability to build strong relationships with regulatory agencies and internal stakeholders.
Preferred Qualifications:
  • BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred.

Corcept Therapeutics is an Equal Opportunity Employer and welcomes applications from diverse candidates. We offer a competitive salary range of $252,000-$296,500, depending on experience and qualifications. Please visit our website for more information on our company culture and benefits.

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