Director, Promotional Review & Labeling Services

ProPharma Group; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

ProPharma Group in the United States seeks a Director, Promotional Review & Labeling Services to lead regulatory review of advertising for consumer, HCP, and managed care materials across brands. You will guide PRC meetings, oversee review workflows, and provide strategic regulatory input to marketing and launch teams.

Candidates bring 7+ years in pharma/biotech regulatory advertising, strong project management, and experience with OPDP submissions and FDA guidances.

Qualifications

• Minimum 7+ years in regulatory advertising and promotion in pharma/biotech.
• Experience leading promotional review and OPDP submissions.
• Strong knowledge of FDA advertising guidance and regulatory processes.

Responsibilities

• Provide compliant regulatory solutions for promotional and advertising review.
• Lead Promotion Review Committee meetings and oversight of review workflows.
• Provide regulatory guidance on campaigns, launches and label changes.
• Coordinate with agencies, stakeholders and operations for submissions.
• Mentor and advise job owners on timing and review processes.
• Stay current on FDA rules and promotional environment.

Skills

Regulatory advertising

OPDP submissions

FDA guidelines

Strategic regulatory guidance

Project management

Remote collaboration

Cross-functional leadership

Communication skills

Education

Bachelor's degree in Life Sciences/Marketing/Business

PharmD preferred

Tools

Veeva Vault PromoMats

Microsoft Office

Adobe Acrobat

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.The **Director, Promotional Review & Labeling Services** is responsible for: * Providing compliant and accurate solutions from a regulatory affairs promotional and advertising review perspective - while providing marketing with competitive solutions for consumer, healthcare provider and managed care materials for all assigned brands.* Acting as lead for Regulatory role during Promotion Review Committee (PRC) meetings and overseeing the promotional review process, as well as other promotion related processes for assigned brands or therapeutic categories.* Reviewing Product launch, Growth brand, Established brand and Derivative materials for assigned projects.* Providing guidance on risk to the PRC and if need be, elevating the risk to their manager/line manager within the client.* Review and approval of all promotional and non-promotional materials for assigned PRC with strong understanding of regulatory advertising and promotion regulations and FDA advertising and promotional Guidances.* Attend prioritization discussions for the assigned PRC.* Evaluate CFL (consistent with FDA approved label) opportunities.* Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.* Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review.* Communicate information provided during promotion review meetings to the broader regulatory team when appropriate.* Clarify rationale and represent regulatory comments on review materials during live PRC meetings.* Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for the initial use (FormFDA 2253).* Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands.* Monitor US regulatory promotional environment by staying up to date on FDA regulations and guidances.* Review of untitled and warning letters to pharmaceutical companies issued by OPDP, APLB, Center for Devices and Radiological Health (CDRH), Federal Trade Commission (FTC), National Advertising Division (NDA) or other governing bodies.* As appropriate, attendance at major FDLI, DIA, and other industry/FDA meetings.* Other duties as assigned. **Necessary Skills and Abilities*** Strong ability to work independently, with flexible and a strong ability to connect and collaborate with clients and team members while working remotely.* Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance and analyze and interpret efficacy and safety data.* Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion, including product launches.* Deep understanding of the advertising/creative development process.* Understanding of pharmaceutical review and approval process.* Experience in leading activities necessary for promotional OPDP submissions.* Experience with using new and social medial platforms for promotion of prescription drugs in the US.* Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. Proficiency in Veeva Vault PromoMats or other electronic review platforms. **Educational Requirements*** A Bachelor's Degree is required, focus in Medical, Science, Marketing, Business or Communications, a PharmD is preferred. **Experience Requirements*** 7+ years of related experience in the pharmaceutical/biotech industry is required. May consider related experience from healthcare advertising agency.* Functional experience in regulatory advertising and promotion required.* Previous experience in medical advertising and promotional review, marketing operations, sales or communications preferred.* Product launch or advertising agency account management experience is a plus.* Strong project and process management experience is required, in pharmaceutical industry is preferred.We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.