Ad Promo Regulatory Advisor

Ad Promo Regulatory Advisor

Job Number:

26-00770 Be part of a company that delivers life-changing healthcare solutions. 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:

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 FDAs 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.

Required Qualifications:

Bachelor's degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD).

Regulatory Experience:

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

Promotional Regulations:

Demonstrated 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 Experience:

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

Project & Stakeholder Management:

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

Leadership & Organizational Skills:

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 If hired, you will enjoy the following

ECLARO Benefits:

401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 212-804-7476 June Binuya |

LinkedIn 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.