Regulatory Affairs Manager (m/f/d) Labeling & Regulatory Intelligence

Merz Therapeutics; Frankfurt; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Frankfurt is seeking a Regulatory Affairs Manager to support regulatory strategies and compliance for medicinal products. The role requires completed studies in natural sciences or pharmacy and offers hybrid work alongside attractive benefits. The ideal candidate will have over 2 years of experience in the pharmaceutical industry, strong project management skills, and business fluency in German and English. Join us and contribute to improving patient quality of life.

Leistungen

Hybrid work model

Attractive remuneration with extensive social benefits

Employer-subsidized benefits such as WellPass and JobBike

Modern workplaces and a company restaurant

Individual career development opportunities

Qualifikationen

• 2+ years of professional experience in pharmaceutical industry and within regulatory affairs.
• Experience with labeling is beneficial.
• Strong knowledge of international regulatory frameworks and standards.

Aufgaben

• Support regional regulatory strategies and approvals for medicinal products.
• Review and implement Company Core Data Sheets (CCDS).
• Coordinate translations and ensure compliance in national product information texts.
• Lead and develop the Regulatory Intelligence process in Global Regulatory Affairs.

Kenntnisse

Strong project management

Analytical thinking

Team player

Excellent communication

Problem-solving abilities

Fluent in German

Fluent in English

Ausbildung

Completed scientific studies in natural sciences or pharmacy

Pharmacist license

Jobbeschreibung

YOUR CONTRIBUTION

As a Regulatory Affairs Manager (m/f/d), you will support regional regulatory strategies, approvals, and the life cycle management of medicinal products, ensuring compliance with regulatory and legal requirements. This position is currently limited to a fixed term of 3 years. Your responsibilities will include the following tasks:

• Review Company Core Data Sheets (CCDS)
• Implement CCDS into national product information texts (EEA/CH/UK), coordinate translations, ensure compliance and timely provision
• Initiate, review, and approve artwork changes (EEA/CH/UK) in close cooperation with local regulatory affairs
• Support submissions and responses to authority queries
• Optimize labeling and artwork processes; train colleagues and act as key user for Merz’ artwork management system
• Lead, monitor and further develop the Regulatory Intelligence process in Global Regulatory Affairs

YOUR PROFILE

• Completed scientific studies in natural sciences or pharmacy; pharmacist license is a plus
• 2+ years of professional experience in pharmaceutical industry and within regulatory affairs; experience with labeling is beneficial
• Strong knowledge of international regulatory frameworks and standards
• Strong project management and analytical thinking ability
• Team player with excellent communication and problem-solving abilities
• Business fluent in German and English

YOUR BENEFITS

• Individual career development in a purposeful job: you improve the quality of life of our patients!
• Hybrid work model that allows a good work‑life balance
• Attractive location with good transport links, modern workplaces and a company restaurant
• Global family business with flat hierarchies and an open, respectful corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer‑subsidized benefits such as WellPass, Deutschland‑ticket, Corporate Benefits and JobBike

Find out more about our benefits here.

ABOUT US

Welcome to Merz Therapeutics, a global leader in specialty neurology, delivering innovative treatments that help people with movement disorders, neurodegenerative conditions, liver disease, and other serious health challenges regain their quality of life.

We are proud to be a family‑owned company with over 117 years of heritage. Our therapies reach patients in more than 80 countries, driven by a passion for innovation and a commitment to growth.

Our goal is to address urgent, unmet medical needs—investing in research, expanding our portfolio, and empowering people to live better lives.

Join our international Merz Therapeutics family and help us achieve our mission:

"BETTER OUTCOMES FOR MORE PATIENTS"