Senior Manager, Regulatory Affairs Advertising & Promotion
Scorpion Therapeutics, Sleepy Hollow Trailer Village, Arizona, United States
Role Summary
The Senior Manager, Regulatory Affairs, Advertising & Promotion leads regulatory advertising and promotion activities across US and global markets for the company’s marketed products and pipeline programs. The role applies clinical development knowledge with an experienced understanding of advertising and promotion regulations to develop key product messages for BLAs and MAAs, while ensuring compliance and corporate integrity. The position provides regulatory advertising and promotion expertise to relevant stakeholders and operates with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Responsibilities
Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as the commercial development of pipeline products, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Creatively advise on the development of product messages and materials across multiple functional areas. Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance. Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal. Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies. Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, maintaining working relationships and effective communication with FDA OPDP reviewers on advertising and promotion matters, including requests for advisory submissions. Ensure compliance with promotional material submissions to FDA on Form 2253. Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications. Maintain vigilance regarding FDA promotional enforcement activities and provide stakeholders with updates and guidance on enforcement impact on company policies. Provide input to direct management on process improvements for promotional review activities and establish portfolio-wide standardization of policies. Cross-train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders. Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports. With minimal guidance from management, provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports submitted to health authorities. Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. Qualifications
Required: A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion. Required: Advanced knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion. Required: Experience with pharmaceutical products. Preferred: Biologics experience is a plus. Preferred: Experience working directly/indirectly with the FDA, specifically OPDP/APLB. Preferred: Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining strong written/verbal communication for strategic regulatory advice. Preferred: Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations. Preferred: Ability to influence cross-functional teams and interact with senior management. Education
Required: Bachelor’s degree (BS) from an accredited College or University in Life Sciences. Preferred: Advanced degree (Masters, PharmD, Ph.D., MD or DO) in medicine or science. Regulatory experience can offset education requirements.
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The Senior Manager, Regulatory Affairs, Advertising & Promotion leads regulatory advertising and promotion activities across US and global markets for the company’s marketed products and pipeline programs. The role applies clinical development knowledge with an experienced understanding of advertising and promotion regulations to develop key product messages for BLAs and MAAs, while ensuring compliance and corporate integrity. The position provides regulatory advertising and promotion expertise to relevant stakeholders and operates with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Responsibilities
Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as the commercial development of pipeline products, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Creatively advise on the development of product messages and materials across multiple functional areas. Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance. Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal. Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies. Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, maintaining working relationships and effective communication with FDA OPDP reviewers on advertising and promotion matters, including requests for advisory submissions. Ensure compliance with promotional material submissions to FDA on Form 2253. Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications. Maintain vigilance regarding FDA promotional enforcement activities and provide stakeholders with updates and guidance on enforcement impact on company policies. Provide input to direct management on process improvements for promotional review activities and establish portfolio-wide standardization of policies. Cross-train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders. Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports. With minimal guidance from management, provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports submitted to health authorities. Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. Qualifications
Required: A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion. Required: Advanced knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion. Required: Experience with pharmaceutical products. Preferred: Biologics experience is a plus. Preferred: Experience working directly/indirectly with the FDA, specifically OPDP/APLB. Preferred: Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining strong written/verbal communication for strategic regulatory advice. Preferred: Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations. Preferred: Ability to influence cross-functional teams and interact with senior management. Education
Required: Bachelor’s degree (BS) from an accredited College or University in Life Sciences. Preferred: Advanced degree (Masters, PharmD, Ph.D., MD or DO) in medicine or science. Regulatory experience can offset education requirements.
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