Ad Promo Regulatory Advisor

Overview Location: 50% onsite Lawrence Township, NJ 08648Duration: 6 MonthsDuration: Initial 06 months (with possibility to extend up to 2 years)Willing to consider self-relocation candidateTop Technical Skills Veeva experience (user level)Technical skills with communication skillsMin 5+ years of experiencePromo Material review experience is a mustRequirements 5+ years of regulatory ad promo review experience3+ years of Oncology Ad Promo review preferred3+ years with MS Office 365Advanced practice degree required (PharmD, JD)Day to Day Activities Need to work cross functionalCandidate will be supporting oncology business; candidates are expected to have a good understanding of US laws implementing medicinal usage.They will also be required to review material offline, however certain materials would be reviewed online with senior authorities and medical representatives.Key Responsibilities Regulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments on a broad range of advertising and promotional materials, sales training content, and external communications for assigned marketed products.Compliance Assurance: Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents. Partner with internal teams to proactively identify and mitigate regulatory risks.Regulatory Intelligence: Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion. Translate regulatory changes into practical business guidance.OPDP Submission Management: Prepare and submit promotional materials to FDA's Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness.Labeling Alignment: Collaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns.#J-18808-Ljbffr