Job Description
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 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
#LI-Remote
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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
