Hybrid Associate Director / Director, Regulatory Affairs, Advertising & Promotion

at Averitas Pharma

• Job title: Associate Director / Director, Regulatory Affairs, Advertising & Promotion
• Job type: Full Time
• Experience level: Lead
• Salary: $175,000 - $240,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Morristown, United States

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)