Scienta
Director, Regulatory Affairs Advertising and Promotion
Scienta, Oklahoma City, Oklahoma, United States
Overview
A fast-growing, science-driven biopharmaceutical company is seeking a Director of Regulatory Affairs (U.S. Advertising & Promotion) to lead it's marketed and late-stage pipeline therapies. This leader will shape regulatory strategy for U.S. advertising and promotion, partnering closely with commercial, medical, and legal counterparts to ensure communications are both compelling and compliant. This role is ideal for a seasoned regulatory professional who thrives on cross-functional collaboration, strategic problem-solving, and influencing. Key Responsibilities
Partner with Commercial, Medical Affairs, Legal, Compliance, and other internal groups to develop and review promotional materials, disease education content, field training resources, and scientific exchange communications. Serve as the Regulatory Reviewer on promotional and medical review committees for assigned products. Act as the primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP) or relevant agencies for assigned brands, including preparing advisory submissions and supporting negotiations. Serve as an internal subject-matter expert on U.S. regulatory requirements, guidance, and enforcement trends related to prescription drug promotion and scientific exchange. Contribute to a culture of compliance by educating colleagues, assessing regulatory risks, and helping shape internal policies and procedures. Monitor evolving legislation, regulations, and agency expectations, communicating implications and recommended actions to cross-functional partners. Provide regulatory input on clinical development and labeling to help enable desirable future claims and target product profiles. Support the growth and maturation of the U.S. Advertising & Promotion function through process optimization and best-practice development. Collaborate with Regulatory Operations to ensure timely and accurate submission of promotional materials to FDA. Qualifications
BS/BA required; advanced degree preferred. 5+ years in U.S. advertising & promotion regulatory roles. Deep knowledge of FDA regulations, guidance documents, and enforcement precedent related to promotional and scientific communications. Experience with product launches and interacting with OPDP or APLB strongly preferred. Exceptional written and verbal communication skills with the ability to translate scientific and legal concepts for diverse audiences. Experience leading or mentoring individuals or teams is beneficial. Strong interpersonal skills and collaborative problem-solving mindset.
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A fast-growing, science-driven biopharmaceutical company is seeking a Director of Regulatory Affairs (U.S. Advertising & Promotion) to lead it's marketed and late-stage pipeline therapies. This leader will shape regulatory strategy for U.S. advertising and promotion, partnering closely with commercial, medical, and legal counterparts to ensure communications are both compelling and compliant. This role is ideal for a seasoned regulatory professional who thrives on cross-functional collaboration, strategic problem-solving, and influencing. Key Responsibilities
Partner with Commercial, Medical Affairs, Legal, Compliance, and other internal groups to develop and review promotional materials, disease education content, field training resources, and scientific exchange communications. Serve as the Regulatory Reviewer on promotional and medical review committees for assigned products. Act as the primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP) or relevant agencies for assigned brands, including preparing advisory submissions and supporting negotiations. Serve as an internal subject-matter expert on U.S. regulatory requirements, guidance, and enforcement trends related to prescription drug promotion and scientific exchange. Contribute to a culture of compliance by educating colleagues, assessing regulatory risks, and helping shape internal policies and procedures. Monitor evolving legislation, regulations, and agency expectations, communicating implications and recommended actions to cross-functional partners. Provide regulatory input on clinical development and labeling to help enable desirable future claims and target product profiles. Support the growth and maturation of the U.S. Advertising & Promotion function through process optimization and best-practice development. Collaborate with Regulatory Operations to ensure timely and accurate submission of promotional materials to FDA. Qualifications
BS/BA required; advanced degree preferred. 5+ years in U.S. advertising & promotion regulatory roles. Deep knowledge of FDA regulations, guidance documents, and enforcement precedent related to promotional and scientific communications. Experience with product launches and interacting with OPDP or APLB strongly preferred. Exceptional written and verbal communication skills with the ability to translate scientific and legal concepts for diverse audiences. Experience leading or mentoring individuals or teams is beneficial. Strong interpersonal skills and collaborative problem-solving mindset.
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