Ad Promo Regulatory Advisor
Alpha Consulting Corp., Lawrenceville, NJ, United States
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
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
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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
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
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