What are the responsibilities and job description for the Regulatory Compliance Manager position at SPECTRAFORCE?
Job Title: Ad Promo Regulatory Advisor
Location: 50% onsite at Princeton Pike
Duration: 6 Months
Hours: Mon-Fri 8 am-5 pm
Pay Range: $ 94-96/hr
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 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.
Required Qualifications
• Educational Background
Bachelor’s 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.
Salary : $94 - $96