Advertising and Promotion Regulatory Advisor (OPDP regulatory advisory experience)

JOB TITLE: Ad Promo Regulatory Advisor Location: Lawrence Township, NJ (HYBRID - 50% onsite)Duration: 6 months initial (potential extension/potential right to hire)Required Qualifications:Experience with prescription drug promotional materialsOPDP aligned regulatory advisory experiencePosition OverviewThe Ad Promo Regulatory Advisor plays a critical role in ensuring that all U.S. advertising, promotional materials, and external communications for marketed pharmaceutical products comply with FDA regulations and industry standards. This position 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 Responsibilities• Regulatory Review & Strategic GuidanceProvide 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 AssuranceEnsure 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 IntelligenceMaintain 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 ManagementPrepare and submit promotional materials to FDAs Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness.• Labeling AlignmentCollaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns.Required Qualifications• Educational BackgroundBachelors degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD).• Regulatory ExperienceMinimum of 5-6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry.• Expertise in Promotional RegulationsDemonstrated experience providing strategic regulatory direction to interdisciplinary teams on promotional strategies and materials. Strong interest and knowledge of FDA promotional regulations and guidance.• Industry or FDA ExperienceBroad hands on pharmaceutical experience or prior FDA regulatory experience (e.g., OPDP) is highly desirable.• Project & Stakeholder ManagementProven ability to manage multiple complex projects, identify and resolve issues, deliver on commitments, and work effectively across multidisciplinary teams.• Leadership & Organizational SkillsStrong leadership presence with the ability to influence, drive alignment, and deliver optimal business results in a dynamic, matrixed environment.If hired, you will enjoy the following Eclaro Benefits:401k Retirement Savings Plan administered by Merrill LynchCommuter Check Pretax Commuter BenefitsEligibility to purchase Medical, Dental & Vision Insurance through EclaroIf you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com or call (212)804-7476.Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.