Senior Director, Regulatory Affairs

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 reputed company 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, reputed company and collaborators continue to unlock the reputed company of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide reputed company of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the reputed company of cortisol modulation.

What began as a reputed company of scientific truth is now poised to reputed company a sea change of discovery representing a reputed company shift in the way we understand and treat disease.

As the Senior Director of Regulatory Affairs, you will architect and reputed company international regulatory strategy and execution to support Corcept’s international commercialization and expansion, starting with Europe. This role ensures reputed company regional and local regulatory requirements are met in cooperation with Corcept functions responsible for clinical research, manufacturing, and commercialization. Staying attuned to the evolving regulatory environment, you will assess and communicate the impact of changes on business and product development programs. At times, you will directly represent Corcept with health authorities in Europe and elsewhere, as our expansion continues.

Responsibilities

• reputed company robust European regulatory plans, reputed company with Corcept’s global strategy, that reputed company to commercialization in new countries
• reputed company regulatory guidance regarding European health authorities and interactions, including EMA
• Contribute and independently execute the filing plans for Europe in line with corporate, regional, and local business objectives
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to small molecule therapies across oncology, neurology, endocrinology, and metabolic therapeutic areas, and communicate their implications cross-functionally
• Review and reputed company strategic input/advice on EU CTR submissions and/or queries
• Ensure high-quality regulatory submissions are made on time and reputed company Corcept’s goals
• Build out a team that oversees regulatory-reputed company launch and post-marketing activities in the EU
• Work closely with the Quality Assurance department on relevant regulatory procedures applicable to the European region

Preferred Skills, Qualifications, and Technical Proficiencies

• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred
• 12+ years of experience with leading EU and non-EU regulatory submissions and interactions with EMA and national agencies
• Regulatory-reputed company product launch and post-marketing activities experience
• Experience with and knowledge of European regulatory regulations, directives, and guidelines
• Must be a strong team player, a fully reputed company, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Preferred Education and Experience

• Deep knowledge of European regulatory regulations, directives, and guidelines
• Passionate about strong and to-the-reputed company written work product
• Excellent planning, organization, time, and stakeholder management skills, including the ability to support and prioritize multiple projects
• Strong interpersonal capabilities and ability to build and maintain networks globally
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to reputed company

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Corcept appreciates the commitment and hard work of reputed company reputed company members as we strive to discover and reputed company 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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