Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
As we expand our portfolio and prepare for commercial entry to the oncology market in the US and EU, we have an exciting opportunity for a Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities.
Responsibilities:

• Delineate regulatory strategies for commercial and corporate communications, in compliance with domestic and foreign legislation
• Provide strategic input on campaigns and product strategy
• 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
• Identify and mitigate regulatory risks
• Manage external regulatory vendors and service providers
• Build relationships with regulatory agencies and represent the company in key meetings
• Review non-promotional materials for regulatory compliance
• Generate regulatory TPPs and draft labeling for pipeline molecules
• Support regulatory inspections and approval strategies for global markets
• Provide key technical and regulatory knowledge for cross-functional teams to ensure internal regulatory compliance

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience managing commercial regulatory strategy and labeling
• Experience leading interactions with health authorities (US and ex-US)
• 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

Preferred Education and Experience:

• BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred
• 12 years of Regulatory Ad/Promo experience

The pay range that the Company reasonably expects to pay for this headquarters-based position is $252,000-$296,500; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
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