Advertising and Promotion Regulatory Advisor (OPDP regulatory advisory experienc

Location: Lawrence Township, NJ (HYBRID - 50% onsite)

Duration: 6 months initial (potential extension/right to hire)

Required Qualifications

Experience with prescription drug promotional materials

OPDP aligned regulatory advisory experience

Bachelors degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD)

Minimum of 5-6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry

Demonstrated experience providing strategic regulatory direction to interdisciplinary teams on promotional strategies and materials

Strong interest and knowledge of FDA promotional regulations and guidance

Broad hands on pharmaceutical experience or prior FDA regulatory experience (e.g., OPDP) is highly desirable

Key Responsibilities

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

Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents, and partner with internal teams to proactively identify and mitigate regulatory risks

Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion and translate regulatory changes into practical business guidance

Prepare and submit promotional materials to FDA’s Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness

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

Proven ability to manage multiple complex projects, identify and resolve issues, deliver on commitments, and work effectively across multidisciplinary teams

Strong leadership presence with the ability to influence, drive alignment, and deliver optimal business results in a dynamic, matrixed environment

Benefits

401k Retirement Savings Plan administered by Merrill Lynch

Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

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.

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