Ad Promo Regulatory Advisor – Pharma (Hybrid – Lawrenceville, NJ)

Ad Promo Regulatory Advisor – Pharma (Hybrid – Lawrenceville, NJ)

We are seeking an Ad Promo Regulatory Advisor for our global pharmaceutical client. The focus of the role is to ensure 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.

This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite at the client’s office in Lawrenceville, NJ

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

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 FDA’s 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.
  
  

Requirements

• Regulatory Experience -Minimum of 5–6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry.
• Veeva experience required
• 3 years with MS Office 365
• 3 years of Oncology Ad Promo review preferred
• 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.
• Bachelor’s degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD).
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Ad Promo Regulatory Advisor – Pharma (Hybrid – Lawrenceville, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $90/hr. - $95.83/hr.