Director, Promotional Review & Labeling Services

For the past 25 years, Pro Pharma 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. Pro Pharma 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, Pro Pharma 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…