Corcept Therapeutics
Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling
Corcept Therapeutics, Menlo Park, California, United States, 94025
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.
Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.Responsibilities:
Delineate regulatory strategies for commercial and corporate communications, in compliance with domestic and foreign legislation
Provide strategic input on campaigns and product strategy
Manage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assets
Lead the development of regulatory submissions of promotional materials for marketed products
Define and advance regulatory strategies for product registration and commercialization
Review and approve product labeling, promotional claims, and advertising
Identify and mitigate regulatory risks
Manage external regulatory vendors and service providers
Build relationships with regulatory agencies and represent the company in key meetings
Review non-promotional materials for regulatory compliance
Generate regulatory TPPs and draft labeling for pipeline molecules
Support regulatory inspections and approval strategies for global markets
Provide key technical and regulatory knowledge for cross-functional teams to ensure internal regulatory compliance
Preferred Skills, Qualifications and Technical Proficiencies:
Experience managing commercial regulatory strategy and labeling
Experience leading interactions with health authorities (US and ex-US)
Understanding of US FDA regulations and international regulatory agencies
Regulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategies
Excellent project management, negotiating, and communication skills
Preferred Education and Experience:
BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred
12+ 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.
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Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.Responsibilities:
Delineate regulatory strategies for commercial and corporate communications, in compliance with domestic and foreign legislation
Provide strategic input on campaigns and product strategy
Manage the strategy and operational aspects of Regulatory labeling for Phase 3 and commercial assets
Lead the development of regulatory submissions of promotional materials for marketed products
Define and advance regulatory strategies for product registration and commercialization
Review and approve product labeling, promotional claims, and advertising
Identify and mitigate regulatory risks
Manage external regulatory vendors and service providers
Build relationships with regulatory agencies and represent the company in key meetings
Review non-promotional materials for regulatory compliance
Generate regulatory TPPs and draft labeling for pipeline molecules
Support regulatory inspections and approval strategies for global markets
Provide key technical and regulatory knowledge for cross-functional teams to ensure internal regulatory compliance
Preferred Skills, Qualifications and Technical Proficiencies:
Experience managing commercial regulatory strategy and labeling
Experience leading interactions with health authorities (US and ex-US)
Understanding of US FDA regulations and international regulatory agencies
Regulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategies
Excellent project management, negotiating, and communication skills
Preferred Education and Experience:
BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred
12+ 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.
#J-18808-Ljbffr