Description
Regulatory Affairs Specialist – Advertising & Promotion
Location: Bridgewater, NJ / Hybrid
Industry: Pharmaceuticals / Life Sciences
Track: Technical (No Direct Reports)
Pay Rate: $61-$91/hour
Overview:
We are seeking an experienced Regulatory Affairs Specialist with a focus on Advertising and Promotion to support the regulatory compliance of promotional, educational, and training materials for marketed products. This role ensures that all promotional activities adhere to applicable U.S. laws, FDA regulations, and company policies, and collaborates cross-functionally to support launch strategies and marketing initiatives.
Key Responsibilities:
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Provide regulatory review and approval of advertising, promotional, and training materials to ensure alignment with FDA, FTC, and internal standards.
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Implement and manage regulatory strategies to support new campaigns, product launches, and lifecycle promotional activities.
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Actively monitor FDA and FTC enforcement actions, guidance documents, and competitor promotions to assess potential impact and mitigate risk.
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Serve as a member of the Promotional Review Committee (PRC), providing expert guidance on regulatory implications for proposed marketing strategies.
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Communicate effectively with regulatory authorities on advertising-related matters, including warning letters and direct challenges.
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Ensure timely review of materials to meet tight internal deadlines and business needs.
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Maintain alignment with the Regulatory Labeling team to assess the promotional impact of proposed labeling changes.
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Support continuous improvement of the ad/promo review process, including the development of training and best practices for internal stakeholders.
Qualifications:
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Bachelor's degree preferred; relevant advanced certifications or training a plus.
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Minimum of 6 years of experience in Regulatory Affairs or within a regulated environment.
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At least 2 years of hands-on experience with prescription drug, OTC, cosmetic, or dietary supplement advertising and promotion review.
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Deep understanding of FDA regulations, guidance documents, and promotional policy enforcement practices.
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Excellent verbal and written communication skills; adept at summarizing complex information clearly.
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Strong project management, prioritization, and organizational skills; comfortable managing multiple tasks under deadline pressure.
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Proficient in Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
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Demonstrated ability to influence cross-functional teams and engage with external regulatory authorities.
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Entrepreneurial mindset with strong business acumen and adaptability.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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