Ad Promo Regulatory Advisor

Job Number: 26-00770

ECLARO

is looking for an

Ad Promo Regulatory Advisor

for our client in

Princeton Pike, NJ .

ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview

The 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.

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. 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. 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.

Required Qualifications

Bachelor’s 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.

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.

Pay Rate:

$95.82 - $101.63 / Hour

Benefits

401k Retirement Savings Plan administered by Merrill Lynch

Commuter Check Pretax Commuter Benefits

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, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

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