Ad Promo Regulatory Advisor in Lawrenceville

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Job Description
Position Overview
The Ad Promo Regulatory Advisor is responsible for ensuring that all U.S. advertising and promotional materials for pharmaceutical products comply with FDA regulations and industry standards. This role partners 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 regulatory advice and risk assessments on promotional materials, sales training content, and external communications
Support cross‑functional teams in developing compliant promotional strategies

Compliance Assurance
Ensure all promotional materials comply with FDA regulations, OPDP guidelines, and approved product labeling
Identify and mitigate regulatory risks proactively

OPDP Submission Management
Prepare and submit promotional materials to FDA’s Office of Prescription Drug Promotion (OPDP)
Manage Form FDA 2253 submissions accurately and on time

Regulatory Intelligence
Stay updated on U.S. regulatory laws, enforcement trends, and policy changes
Translate regulatory updates into actionable business guidance

Labeling Alignment
Ensure consistency between promotional materials and current prescribing information
Collaborate with internal stakeholders on labeling updates

Required Qualifications
Education
Bachelor’s degree in Life Sciences or related field
Advanced degree required: PharmD or JD

Experience
5+ years of regulatory advertising & promotion (Ad Promo) review experience
3+ years of Oncology Ad Promo experience
Strong experience with

FDA promotional regulations and OPDP

Technical Skills
Hands‑on experience with

Veeva Vault

(required)
Proficiency in

MS Office 365

Additional Skills
Strong project and stakeholder management abilities
Ability to work in a fast‑paced, matrixed environment
Excellent communication and leadership skills

Qualifications
Prior experience working with the FDA or OPDP
Pharmaceutical or biotech industry background
Experience handling complex promotional review processes

Work Requirements
Ability to manage multiple projects and deadlines effectively

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.

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