Ad Promo Regulatory Advisor
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Job Location:
Lawrenceville, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Ad Promo Regulatory Advisor
Location: 50% onsite at Princeton Pike
Hours: Mon-Fri 8am-5pm
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 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.
Location: 50% onsite at Princeton Pike
Hours: Mon-Fri 8am-5pm
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 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.
