Senior Director Regulatory Affairs

2 days 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 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 robust and compliant.
  • Manage external regulatory vendors and service providers, ensuring effective collaboration and communication.
  • 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 the company's messaging is accurate and compliant.
  • Generate regulatory TPPs and draft labeling for pipeline molecules, ensuring alignment with regulatory requirements.
  • Support regulatory inspections and approval strategies for global markets, ensuring the company's regulatory posture is robust and compliant.
Requirements:
  • 12+ years of experience in Regulatory Affairs, with a focus on commercial regulatory strategy and labeling.
  • Experience leading interactions with health authorities (US and ex-US) and regulatory agencies.
  • Understanding of US FDA regulations and international regulatory agencies, with a focus on IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategies.
  • Excellent project management, negotiating, and communication skills, with the ability to effectively collaborate with cross-functional teams.
Preferred Qualifications:
  • BA/BS Degree in health/life sciences or related field, with an advanced degree (PharmD, PhD, MS) highly preferred.

Corcept Therapeutics is an Equal Opportunity Employer and welcomes applications from diverse candidates. Please visit our website for more information on our company culture and benefits.

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