Ad Promo Regulatory Advisor (Lawrenceville)

Position OverviewThe Ad Promo Regulatory Advisor is responsible for ensuring that all U.S. advertising and promotional materials for pharmaceutical products comply with FDA regulations and industry standards. This role partners 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 GuidanceProvide regulatory advice and risk assessments on promotional materials, sales training content, and external communicationsSupport cross-functional teams in developing compliant promotional strategiesCompliance AssuranceEnsure all promotional materials comply with FDA regulations, OPDP guidelines, and approved product labelingIdentify and mitigate regulatory risks proactivelyOPDP Submission ManagementPrepare and submit promotional materials to FDA's Office of Prescription Drug Promotion (OPDP)Manage Form FDA 2253 submissions accurately and on timeRegulatory IntelligenceStay updated on U.S. regulatory laws, enforcement trends, and policy changesTranslate regulatory updates into actionable business guidanceLabeling AlignmentEnsure consistency between promotional materials and current prescribing informationCollaborate with internal stakeholders on labeling updatesRequired QualificationsEducationBachelor's degree in Life Sciences or related fieldAdvanced degree required/preferred: PharmD or JDExperience5+ years of regulatory advertising & promotion (Ad Promo) review experience3+ years of Oncology Ad Promo experience preferredStrong experience with FDA promotional regulations and OPDPTechnical SkillsHands-on experience with Veeva Vault (required)Proficiency in MS Office 365Additional SkillsStrong project and stakeholder management abilitiesAbility to work in a fast-paced, matrixed environmentExcellent communication and leadership skillsPreferred QualificationsPrior experience working with the FDA or OPDPPharmaceutical or biotech industry backgroundExperience handling complex promotional review processesWork RequirementsAbility to manage multiple projects and deadlines effectively