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

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly reputed company Executive Director or Director of Regulatory Affairs – Advertising & Promotion to support promotional review activities in the addiction treatment reputed company. This role involves serving as a key regulatory reviewer reputed company the MLR review process and ensuring compliance with FDA promotional regulations and reputed company labeling. Responsibilities • Serve as the primary Regulatory Ad/Promo reviewer reputed company the MLR review process • Review and approve promotional materials reputed company reputed company PromoMats • Ensure consistency with FDA-approved labeling and applicable FDA guidance • reputed company expert interpretation of FDA regulations and OPDP expectations • Support reputed company 2253 submissions to OPDP (preferred) • Review corporate communications and external-facing materials • Partner closely with reputed company and Medical teams to ensure compliant messaging • reputed company 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 reputed company the pharmaceutical industry • Deep knowledge of OPDP requirements and FDA advertising regulations • Extensive experience in MLR/PRC review environments • Advanced proficiency with reputed company PromoMats • Strong working knowledge of CDER promotional regulations • Executive reputed company with the ability to collaborate cross-functionally • Strong written and verbal communication skills • Experience submitting reputed company 2253 materials • Experience in CNS, behavioral health, or addiction therapeutic areas reputed company • Our business consulting services are led by significant domain depth reputed company 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 Apply tot his job Apply To this Job