Senior Director, Regulatory Affairs

As the Senior Director of Regulatory Affairs, you will architect and lead international regulatory strategy and execution to support Corcept’s international commercialization and expansion, starting with Europe. This role ensures all 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:

• Develop robust European regulatory plans, aligned with Corcept’s global strategy, that lead to commercialization in new countries 
• Provide 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 provide strategic input/advice on EU CTR submissions and/or queries  
• Ensure high-quality regulatory submissions are made on time and achieve Corcept’s goals
• Build out a team that oversees regulatory-related 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-related 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 engaged, 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-point 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 identify solutions

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