Lead Regulatory Affairs Promotional Review Specialist

2 weeks ago

Western Springs, Illinois, United States ProPharma Group Full time

For over two decades, ProPharma has been dedicated to enhancing patient health and wellness by offering expert guidance that empowers biotech, medical device, and pharmaceutical organizations of all sizes to confidently navigate scientific advancements and launch new therapies. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate model throughout the entire product lifecycle. With extensive expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma provides a complete suite of customizable consulting solutions designed to mitigate risks and expedite our partners' most significant drug and device initiatives.

Position Overview

The Senior Consultant for Regulatory Promotional Review will be responsible for:

  • Delivering compliant and precise solutions from a regulatory affairs perspective concerning promotional and advertising reviews, while offering marketing competitive insights for consumer, healthcare provider, and managed care materials across all assigned brands.
  • Leading the Regulatory role during Promotion Review Committee (PRC) meetings and managing the promotional review process, along with other promotion-related activities for designated brands or therapeutic categories.
  • Evaluating Product launch, Growth brand, Established brand, and Derivative materials for assigned projects.
  • Providing risk assessments to the PRC and, if necessary, escalating concerns to their manager/line manager within the client organization.
Key Responsibilities
  • Reviewing and approving all promotional and non-promotional materials for assigned PRC, with a robust understanding of regulatory advertising and promotion regulations and FDA guidelines.
  • Participating in prioritization discussions for the assigned PRC.
  • Assessing opportunities consistent with FDA-approved labeling.
  • Offering regulatory guidance on advertising and promotional materials, new campaigns, and launch strategies.
  • Counseling job owners on planning for the review process, including timing considerations, review types, and relevant guidance documents.
  • Communicating insights from promotion review meetings to the broader regulatory team when appropriate.
  • Clarifying rationale and representing regulatory feedback on review materials during live PRC meetings.
  • Collaborating with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use.
  • Partnering with job owners and other stakeholders in executing job reapprovals and tactics related to label changes for assigned brands.
  • Monitoring the US regulatory promotional landscape by staying informed on FDA regulations and guidelines.
  • Reviewing untitled and warning letters issued to pharmaceutical companies by OPDP, APLB, CDRH, FTC, NAD, or other governing bodies.
  • Attending major FDLI, DIA, and other industry/FDA meetings as appropriate.
Required Skills and Qualifications
  • Ability to work independently with flexibility and a strong capacity to connect and collaborate with clients and team members in a remote setting.
  • Proven capability to provide strategic direction and innovative regulatory guidance, along with analyzing and interpreting efficacy and safety data.
  • Familiarity with FDA and pharmaceutical regulatory and compliance guidelines regarding advertising and promotion, including product launches.
  • Comprehensive understanding of the advertising and creative development process.
  • Knowledge of the pharmaceutical review and approval process.
  • Experience leading activities necessary for promotional OPDP submissions.
  • Experience utilizing new and social media platforms for the promotion of prescription drugs in the US.
  • Proficiency in computer applications, including Microsoft Office and Adobe Acrobat, and familiarity with Veeva Vault Promo Mats or other electronic review platforms.
Educational Background

A Bachelor's degree is required, preferably in Medical, Science, Marketing, Business, or Communications; a PharmD is preferred.

Experience Requirements
  • A minimum of 7 years of relevant experience in the pharmaceutical or biotech industry is required. Related experience from healthcare advertising agencies may be considered.
  • Functional experience in regulatory advertising and promotion is required.
  • Previous experience in medical advertising and promotional review, marketing operations, sales, or communications is preferred.
  • Experience in product launch or advertising agency account management is a plus.
  • Strong project and process management experience is required, preferably in the pharmaceutical industry.
We celebrate our differences and strive to create a workplace where each individual can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe environment where all employees feel empowered to succeed.

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