Ad Promo Regulatory Advisor

LanceSoft Inc

Job Title: Ad Promo Regulatory Advisor

Location: 50% onsite at 3401 Princeton Pike, Lawrence Township, NJ 08648

Duration: 6 Months

Hours: Mon-Fri 8am-5pm

Requirements:

5+ years of regulatory ad promo review experience
3+ years of Oncology Ad Promo review preferred
Veeva experience required
3+ years with MS Office 365
Advanced practice degree required (PharmD, JD)

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.

Key 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

Educational Background: Bachelors degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD).
Regulatory Experience: Minimum of 56 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.

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Vacancy posted 3 days ago

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