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Years of Experience
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Senior Regulatory Affairs Specialist - Post-Market Advertising, Labeling and Promotion The candidate will focus primarily on Post-Market Advertising, Labeling and Promotion. Will partner with internal stakeholders, and provide regulatory expertise and guidance needed for compliance of promotional material. Will review advertising, labeling, promotional, and other related materials to ensure compliance with applicable FDA/FTC laws, regulations, and guidance. Provide regulatory guidance to marketing teams for post market materials from concept through review and approval for DTC advertising, labeling and promotional materials, while maintaining compliance with governing FDA/FTC regulations and company policies. Review labeling and promotional documents for accuracy and adherence to regulatory requirements, while ensuring a complimentary brand voice. Collaborate with marketing teams to support development of a variety of different types of consumer media, including display advertising, radio ads, email communications, social media, press, affiliate communication, blogs, video content, retail marketing and event materials. Work collaboratively with content developers to ensure brand voice is heard throughout all communications materials. Provide guidance to marketing teams to ensure consistency and efficiency in material and ideation/development. Partner with other departments to review and approve marketing materials that target audiences such as healthcare providers, academics and the scientific community. Ensure labeling changes are reviewed and if appropriate, implemented into advertising and promotional materials. Contribute to the development and implementation of policies and procedures for review and approval of marketing and promotional materials and documents. Monitor regulations, guidance, and regulatory or legal actions from the FDA, FTC, or competitors that may influence the landscape.
Qualification and Experience
The candidate must have Bachelor's degree in life science; an advanced degree is preferred (JD degree, MS, PhD). Should have 5-7 years previous experience in regulated industry with a strong knowledge of global regulations and interpretation relevant to OTC/DTC advertising and promotion. Must have strong understanding of 21 CFR 809.10, 21 CFR 820, ISO 13485, and ISO 14971. Should have comprehensive understanding of relevant advertising and promotional regulations and guidances. Should have experience reviewing content for multiple media channels (website, radio and video scripts, banner ads, etc.). Must be expert level use of Word, Excel, and PowerPoint and experience with document management systems and document sharing systems.
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