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 practices and submission guidelines.
  • Drive continuous improvement using data and metrics (cycle time, quality, deviation patterns, risk themes) to enhance efficiency, consistency, and audit readiness globally.
• Corporate Advisement:
  • Contribute to the development and implementation of corporate policies and procedures for regulation of promotional materials and other external communications such as social media policies and press releases.
  • Drive global guidance and interpretation standards for promotional compliance topics, ensuring consistent application across regions and functions and enabling decision-making at senior levels.
• Employee Training:
  • Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products.
  • Establish a scalable, role-based training strategy that embeds compliant behavior into day-to-day commercial execution (prevention vs correction).
• Industry Advisement:
  • Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement actions.
  • Translate external developments into proactive risk assessments and strategic recommendations and advise internal stakeholders on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales and Marketing and other product-related teams.
• R&D Leadership:
  • Provide guidance on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries.

Minimum Requirements

• Bachelor's Degree In Scientific or Health Discipline
• 12 years Of pharmaceutical/medical device industry experience and minimum of 5 years as a regulatory affairs reviewer of advertising and promotional materials
• 5 years Must have a proven track record of managing direct reports, successful internal stakeholder management and collaboration, communication, and interacting with FDA and OPDP

Preferred Qualifications

• Master's Degree Or Higher Education

Technical & Functional Skills

• Advanced skills with all MS Office applications and comfort with a variety of digital communication tools and AV equipment
• Experience with social media platforms and their use in the context of drug and device advertising, promotion, and labeling
• Strong attention to detail. Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
• Strong communication and presentation skills, both written and verbally, Business fluent in English
• Team player, proven ability to collaborate cross-functionally in a complex, global matrix environment
• Excellent organizational, prioritization and planning skills.
• Ability to work independently on projects and initiatives internally and with external vendors.
• Confident and able to influence key stakeholders.
• Expert knowledge of FDA and FTC regulations and guidance pertaining to drug and device advertising, promotion, and labeling
• Familiarity with EU Advertising and Promotional Compliance requirements