Regulatory Affairs Manager (mfd) Labeling & Regulatory Intelligence

Frankfurt am Main - Germany

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

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 benefitshere.

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 needsinvesting 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

Required Experience:

Unclear Seniority

YOUR CONTRIBUTIONAs 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 respo...