Specialist Regulatory Operations (m/f/d)

YOUR CONTRIBUTION

As a Specialist Regulatory Operations (m/f/d), you will provide operational regulatory support focusing on documentation, legalization processes, and coordination of global submission activities. You will ensure the timely provision of high-quality regulatory documentation in line with regulatory and legal requirements. The position is limited to 3 years and includes the following activities:

 

• Document Legalisation: Coordinate legalisation of documents for global registrations
• Documentation Management: Create and maintain regulatory documents in line with standards
• RIMS & Data Management: Maintain regulatory systems and ensure high data quality
• Dossier Preparation: Support the preparation and submission of regulatory dossiers
• Coordination: Collaborate with internal teams and external partners (e.g. authorities, service providers)
• Process Tracking: Monitor regulatory processes and ensure proper documentation

YOUR PROFILE

• Completed relevant education (e.g. legal assistant, pharmaceutical technical assistant, medical documentarian,admin background)
• Experience in Regulatory Affairs or comparable environment (pharma preferred)
• Understanding of regulatory processes and documentation
• Experience with regulatory systems/tools (e.g. RIMS, Jira)
• Fluent English (min. B2)
• Structured, reliable, detail-oriented working style

 

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 leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.

We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:
"BETTER OUTCOMES FOR MORE PATIENTS"