Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history.

As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine.

Our purpose is to fuel confidence by helping people look better, feel better, and live better.

We believe you do not have to choose between living life and making a living.

Live your best life with Merz Aesthetics.

A Brief Overview

Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents.

Define and execute the global Advertising & Promotional Compliance strategy and governance framework, including standards, decision rights, escalation pathways, and risk posture for compliant promotion across geographies and product categories.

The individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders.

What You Will Do


* Leadership:
+ Provide global leadership for and manage regulatory aspects of the copy review / approval process for promotional materials and ensure compliance of promotional materials with laws, including FDA and notified body regulations and published guidance documents.
+ Define global standards for promotional compliance decision-making, ensuring consistent interpretation and application across functions and regions.
+ Hire, train, supervise, and provide leadership to direct reports in the execution of their roles within the advertising and promotional review regulatory team.


* Cross-Functional Leadership:
+ Work closely with R&D project teams to advise on projects and advise on new products, indications and launches.


* Regulatory Oversight:
+ Oversee the regulatory aspects of reviewing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP).

Oversee timely and accurate submission of promotional materials to OPDP.


* Process Leadership:
+ Develop and maintain SOPs and processes for review, approval and submission of advertising and promotional materials to the FDA.

Work closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review process, establishing consistent best pract...