Ad Promo Regulatory Advisor (Lawrenceville)
Alpha Consulting Corp., Lawrenceville, NJ, United States
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/preferred:
PharmD or JD
Experience 5+ years of regulatory advertising & promotion (Ad Promo) review experience 3+ years of Oncology Ad Promo experience preferred 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
Preferred 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
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/preferred:
PharmD or JD
Experience 5+ years of regulatory advertising & promotion (Ad Promo) review experience 3+ years of Oncology Ad Promo experience preferred 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
Preferred 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