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