For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
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
- 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
- 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
Corcept is an Equal Opportunity Employer
#J-18808-Ljbffr€100000 - €140000 monthly