[Remote] Director, Regulatory Affairs – Advertising & Promotion (Ad Promo)

Note: The job is a remote job and is open to candidates in USA. KPG99 INC is seeking a highly experienced Executive Director or Director of Regulatory Affairs – Advertising & Promotion to support promotional review activities in the addiction treatment space. This role involves serving as a key regulatory reviewer within the MLR review process and ensuring compliance with FDA promotional regulations and current labeling. Responsibilities • Serve as the primary Regulatory Ad/Promo reviewer within the MLR review process • Review and approve promotional materials within Veeva PromoMats • Ensure consistency with FDA-approved labeling and applicable FDA guidance • Provide expert interpretation of FDA regulations and OPDP expectations • Support Form 2253 submissions to OPDP (preferred) • Review corporate communications and external-facing materials • Partner closely with Legal and Medical teams to ensure compliant messaging • Act as an SME on evolving FDA promotional guidance and labeling updates • Escalate regulatory risks appropriately and professionally Skills • 10+ years of hands-on Regulatory Ad/Promo experience within the pharmaceutical industry • Deep knowledge of OPDP requirements and FDA advertising regulations • Extensive experience in MLR/PRC review environments • Advanced proficiency with Veeva PromoMats • Strong working knowledge of CDER promotional regulations • Executive presence with the ability to collaborate cross-functionally • Strong written and verbal communication skills • Experience submitting Form 2253 materials • Experience in CNS, behavioral health, or addiction therapeutic areas Company Overview • Our business consulting services are led by significant domain depth built on a robust technology-driven services platform. It was founded in 2013, and is headquartered in Hampton, New Jersey, USA, with a workforce of 51-200 employees. Its website is Apply tot his job

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