Ad Promo Regulatory Advisor (Lawrence)

Job Title: Ad Promo Regulatory AdvisorDuration: 06 Months-ContractLocation: 50% onsite – Lawrence Township NJ 08648Hours: Monday–Friday | 8:00 AM – 5:00 PMPosition OverviewThe Ad Promo Regulatory Advisor ensures U.S. advertising, promotional materials, and external communications for marketed pharmaceutical products comply with FDA regulations and industry standards. This role partners closely with cross-functional teams to provide strategic regulatory guidance, assess risk, and support compliant product promotion in a fast-paced, matrixed environment.Key ResponsibilitiesRegulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments across advertising and promotional materials, sales training content, and external communications for assigned products.Compliance Assurance: Ensure all promotional activities comply with FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance. Proactively identify and mitigate regulatory risks with internal teams.Regulatory Intelligence: Stay current on U.S. federal and state regulations, enforcement trends, and policy updates affecting pharmaceutical advertising and promotion, translating changes into practical business guidance.OPDP Submission Management: Prepare and submit promotional materials to the FDA Office of Prescription Drug Promotion (OPDP) using Form FDA 2253, ensuring accuracy, completeness, and timeliness.Labeling Alignment: Partner with cross-functional stakeholders to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns.Required QualificationsBachelor's degree in Life Sciences required; advanced degree (MS, PhD, PharmD, or JD) strongly preferred.5–6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry.Proven expertise in FDA promotional regulations and providing strategic regulatory direction to interdisciplinary teams.Prior pharmaceutical industry experience or FDA regulatory experience (e.g., OPDP) highly preferred.Strong project and stakeholder management skills, with the ability to manage multiple priorities in a matrixed environment.Demonstrated leadership presence with the ability to influence stakeholders and drive alignment.