Director, Regulatory Affairs Advertising & Promotion, US

Grunenthal•Morristown, NJ

About The Position

The Director, Regulatory Affairs Advertising & Promotion, US is responsible for developing and executing regulatory strategies for all advertising and promotional activities in the United States. This role serves as the primary expert on FDA requirements for the review of promotional, disease‑state, and scientific exchange materials, ensuring all communications comply with applicable regulations. The position provides strategic regulatory guidance to US commercial teams, offering risk‑based recommendations to support the planning and execution of marketing initiatives. Additionally, the role ensures that cross‑functional advertising and promotion review teams operate effectively, follow established processes, and drive timely, compliant decision‑making.

Requirements

Bachelor’s degree in scientific discipline; advanced degree preferred.
A minimum of 7 years of Regulatory Affairs experience with a focus on US regulatory affairs, including advertising and promotional regulations.
Strong verbal and written communication skills; able to engage and influence stakeholders at all levels, both internally and externally.
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.
Ability to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities.
Flexible, pragmatic, solution-oriented, independent and proactive working style.
Strong ability to articulate regulatory rationale, influence cross-functional partners, and support balanced, compliant decision-making.
Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor.
High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers.
Operates in compliance with all applicable regulations and professional standards at all times.

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.