Compliance Analyst role at Leve Saúde ensuring adherence to regulations in the health sector. Responsibilities include audits, policy management, and due diligence processes.
AP
Hybrid Associate Director / Director, Regulatory Affairs, Advertising & Promotion
Posted 2 months ago
About the role
- US Regulatory Affairs Associate Director/Director at Averitas developing strategies for FDA compliance in advertising. Leading cross-functional collaboration and managing promotional materials review under US regulations.
Responsibilities
- Lead and manage the US Materials Review processes (LMR & PARC), ensuring robust procedures for the creation, review, and approval of promotional, non‑promotional, scientific exchange, and external communications that meet all regulatory requirements and support operational excellence
- Ensure compliant review and approval of all professional and direct‑to‑consumer promotional and non‑promotional materials for approved US products managed by Averitas
- Oversee review of materials for investigational products, ensuring all US-facing materials adhere to FDA regulations and avoid any implication of pre‑approval promotion
- Build strong partnerships and collaborate effectively with cross-functional Medical, Legal, and other LMR team members to enable timely, aligned decision‑making
- Serve as the Subject Matter Expert on FDA advertising and promotion regulations, providing strategic guidance on promotional concepts, launch strategies, branding, campaigns, and materials for both approved and investigational products
- Collaborate with Global Regulatory Affairs to ensure US promotional and sales training materials reflect current US prescribing information and align with global product strategy where appropriate
- Act as the primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP), including oversight of FDA Form 2253 submissions for assigned products
- Advise US Commercial teams on regulatory requirements and risk‑based best practices to support compliant planning and execution of marketing strategies
- Partner with Global Regulatory Affairs on the development, review, and approval of US labeling (e.g., carton/container labeling and US prescribing information)
- Ensure consistent application of regulatory standards across US Materials Review teams and verify adherence to established processes, documentation practices, and governance expectations
- Represent US Commercial Regulatory in relevant cross-functional initiatives, including committees, training programs, and due diligence activities
- Lead additional regulatory activities as assigned beyond advertising and promotion, contributing to broader regulatory initiatives as needed
- Provides guidance and oversight to Regulatory Affairs team members and contractors as needed, fostering a collaborative, high‑performance working environment grounded in regulatory excellence, trust, and proactive partnership
- Partner cross-functionally to drive consistency, efficiency, quality, and compliance, providing clear, balanced regulatory risk assessments and facilitating productive risk‑benefit discussions
Requirements
- A minimum of 7 years of Regulatory Affairs experience with a focus on US regulatory affairs, including advertising and promotional regulations
- Bachelor's degree in scientific discipline; advanced degree preferred
- Direct experience engaging with FDA, preferably including interactions with the Office of Prescription Drug Promotion (OPDP)
- Developed and executed innovative regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction
- Experience with labeling development and life-cycle management
- Extensive knowledge of US regulatory environment including FDA regulations, guidance documents, enforcement trends, and best practices related to advertising, promotion, and scientific exchange
- Experience participating in or leading cross-functional materials review committees (LMR)
- Strong understanding of the competitive landscape, with the ability to monitor regulatory and promotional trends and translate insights into actionable US regulatory intelligence for commercial partners
- Strong project management and negotiation skills
Benefits
- annual performance bonus target of 20%/base salary (subject to meeting plan requirements)
- comprehensive health benefits (employer funded)
- unlimited vacation time
- 401k plan (subject to change or modification from time to time)
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