Advanced Recruiting Partners
Responsibilities
Serve as the regulatory lead on promotional review committees for the Americas region (U.S. and Canada), ensuring timely and compliant review of promotional and non-promotional materials. Provide strategic regulatory guidance to cross-functional partners (Marketing, Legal, Medical Affairs, Market Access) during content development. Ensure materials are compliant with FDA and Health Canada promotional regulations and guidance. Prepare and submit promotional materials to regulatory agencies. Monitor regulatory trends and enforcement actions to inform promotional strategy and risk mitigation. Support internal and external training on promotional regulations, company policies, and best practices. Contribute to the development and implementation of internal SOPs and processes related to promotional review. Collaborate with Global Regulatory Affairs and other regions to align on messaging, compliance strategy, and regulatory interpretations. Provide regulatory input on product labeling and core communication documents used in promotional materials. Qualifications
Bachelor’s degree in a scientific discipline; advanced degree (PharmD, PhD, MD) preferred. Minimum of
5 years of experience
in U.S. regulatory affairs, with
at least 2 years in advertising and promotion review . Experience working on
rare disease
products or specialty therapeutics preferred. In-depth knowledge of FDA regulations, guidance documents, and Health Canada promotional review processes. Strong interpersonal skills with the ability to work effectively in cross-functional teams. Excellent written and verbal communication skills. Experience using promotional review systems (e.g., Veeva PromoMats) a plus. Ability to balance compliance and business needs in a fast-paced, dynamic environment.
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Serve as the regulatory lead on promotional review committees for the Americas region (U.S. and Canada), ensuring timely and compliant review of promotional and non-promotional materials. Provide strategic regulatory guidance to cross-functional partners (Marketing, Legal, Medical Affairs, Market Access) during content development. Ensure materials are compliant with FDA and Health Canada promotional regulations and guidance. Prepare and submit promotional materials to regulatory agencies. Monitor regulatory trends and enforcement actions to inform promotional strategy and risk mitigation. Support internal and external training on promotional regulations, company policies, and best practices. Contribute to the development and implementation of internal SOPs and processes related to promotional review. Collaborate with Global Regulatory Affairs and other regions to align on messaging, compliance strategy, and regulatory interpretations. Provide regulatory input on product labeling and core communication documents used in promotional materials. Qualifications
Bachelor’s degree in a scientific discipline; advanced degree (PharmD, PhD, MD) preferred. Minimum of
5 years of experience
in U.S. regulatory affairs, with
at least 2 years in advertising and promotion review . Experience working on
rare disease
products or specialty therapeutics preferred. In-depth knowledge of FDA regulations, guidance documents, and Health Canada promotional review processes. Strong interpersonal skills with the ability to work effectively in cross-functional teams. Excellent written and verbal communication skills. Experience using promotional review systems (e.g., Veeva PromoMats) a plus. Ability to balance compliance and business needs in a fast-paced, dynamic environment.
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