Corcept Therapeutics
Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling
Corcept Therapeutics, Menlo Park, California, United States, 94029
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 we expand our portfolio and prepare for commercial entry to the oncology market in the US and EU, we have an exciting opportunity for a Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities.
Responsibilities:
Delineate regulatory strategies for commercial and corporate communications, in compliance with domestic and foreign legislationProvide strategic input on campaigns and product strategyManage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assetsLead the development of regulatory submissions of promotional materials for marketed productsDefine and advance regulatory strategies for product registration and commercializationReview and approve product labeling, promotional claims, and advertisingIdentify and mitigate regulatory risksManage external regulatory vendors and service providersBuild relationships with regulatory agencies and represent the company in key meetingsReview non-promotional materials for regulatory complianceGenerate regulatory TPPs and draft labeling for pipeline moleculesSupport regulatory inspections and approval strategies for global marketsProvide key technical and regulatory knowledge for cross-functional teams to ensure internal regulatory compliancePreferred Skills, Qualifications and Technical Proficiencies:
Experience managing commercial regulatory strategy and labelingExperience leading interactions with health authorities (US and ex-US)Understanding of US FDA regulations and international regulatory agenciesRegulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategiesExcellent project management, negotiating, and communication skillsPreferred Education and Experience:
BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred12+ years of Regulatory Ad/Promo experience
The pay range that the Company reasonably expects to pay for this headquarters-based position is $252,000-$296,500; 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.
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.
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 we expand our portfolio and prepare for commercial entry to the oncology market in the US and EU, we have an exciting opportunity for a Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities.
Responsibilities:
Delineate regulatory strategies for commercial and corporate communications, in compliance with domestic and foreign legislationProvide strategic input on campaigns and product strategyManage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assetsLead the development of regulatory submissions of promotional materials for marketed productsDefine and advance regulatory strategies for product registration and commercializationReview and approve product labeling, promotional claims, and advertisingIdentify and mitigate regulatory risksManage external regulatory vendors and service providersBuild relationships with regulatory agencies and represent the company in key meetingsReview non-promotional materials for regulatory complianceGenerate regulatory TPPs and draft labeling for pipeline moleculesSupport regulatory inspections and approval strategies for global marketsProvide key technical and regulatory knowledge for cross-functional teams to ensure internal regulatory compliancePreferred Skills, Qualifications and Technical Proficiencies:
Experience managing commercial regulatory strategy and labelingExperience leading interactions with health authorities (US and ex-US)Understanding of US FDA regulations and international regulatory agenciesRegulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategiesExcellent project management, negotiating, and communication skillsPreferred Education and Experience:
BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred12+ years of Regulatory Ad/Promo experience
The pay range that the Company reasonably expects to pay for this headquarters-based position is $252,000-$296,500; 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.
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.