Senior Director, Legal (Regulatory Compliance)

Corcept Therapeutics is preparing to launch new products in multiple therapeutic areas and markets both in the US and EU over the next few years. We have an exciting opportunity for a Senior Director, Regulatory Compliance to lead the design, implementation and management of systems and talent to ensure that externally-facing promotional and non-promotional materials related to commercialized and emerging products are compliant with regulatory requirements. This role will involve broad operational and strategic responsibilities.

Responsibilities :

• Provide regulatory strategic oversight for multiple therapeutic areas and products to ensure regulatory compliance of promotional and non-promotional materials generated for external communication regarding commercialized products and / or compounds in development.
• Understand and interpret complex regulatory requirements applicable to use of product and disease related communications by pharmaceutical companies.
• Serve as the chair of review meetings overseeing approval of externally-facing content designed to communicate promotional and non-promotional messages regarding commercialized products and products in development.
• Mentor and develop staff and subject matter expertise by providing training and regular updates on existing and new regulatory requirements.
• Serve as primary liaison with Regulatory Affairs for communications with OPDP and / or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for FDA-approved products.
• Ensure efficient and consistent application of Corcept’s materials review system to operationalize and document collaborative review / approval by subject matter experts of materials related to disease areas, commercialized products and product development efforts.
• Develop and update standard operating procedures for materials content review and approval.
• Support metrics to measure and track the effectiveness and efficiency of the materials content review process and provide recommendations for process improvements to address potential issues.
• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, Ad Agencies, and Compliance to ensure alignment and effective execution of corporate objectives while mitigating potential regulatory compliance risk.
• Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug products and communication of scientific and other information regarding company products and therapeutic endeavors.
• Present to Corcept leadership and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and / or guidance documents.
• Proactively identify regulatory compliance issues related to use of proposed promotional and non-promotional materials and offer creative risk mitigation solutions.
• Collaborate with the Regulatory team to provide product and label development strategies, as needed, to ensure promotional campaigns can be supported.
• May provide direct supervision of individuals including mentoring, performance management, and staffing decisions.
• Identify and propose solutions to management for any resource gaps for continued compliance oversight.
• Collaborate with the International Regulatory Ad / Promo review team(s) / advisors for materials that are intended for global audiences (e.g., global press releases, new global campaigns, conference booth presence).

Preferred Skills, Qualifications and Technical Proficiencies :

Preferred Education and Experience :

The pay range that the Company reasonably expects to pay for this headquarters-based position is $258,400 - $304,000; 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.

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Salary : $258,400 - $304,000