Regulatory Promotional Review Consultant - Brazil

For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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 Regulatory Promotional Review Consultant 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 oversee the promotional review process, as well as other promotion related processes for assigned brands or therapeutic categories.
• Review of both established brands 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.

Essential functions:

• Review and approval of all promotional and non-promotional materials for assigned PRC with strong understanding of regulatory advertising and promotion regulations and Anvisa advertising and promotional guidances.
• Attend prioritization discussions for the assigned PRC.
• Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review.
• Communication information provided during promotion review meetings to the broader regulatory team when appropriate and elevating risk items to management.
• 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 the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB).
• Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands.
• Monitor Anvisa regulatory promotional environment by staying up to date on regulations and guidances.
• Other duties as assigned.

Necessary Skills & Abilities

• Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
• Proven ability to provide strategic direction and innovate, forward thinking regulatory guidance and analyze and interpret efficacy and safety data.
• Working knowledge of pharmaceutical regulatory and compliance guidelines on advertising and promotion, including product launches.
• Deep understanding of the advertising/creative development process.
• Understanding of pharma review and approval process.
• 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

• 5+ years of related experience in pharma/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.
• Strong project and process management experience is required, in pharmaceutical industry is preferred.

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