BP Regulatory Affairs Manager

Your challenges

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance
• Review documents to ensure alignment regarding GMP customer expectations and suitability in the framework of GMP guidelines
• Provide target group specific trainings and participate in global broadcast presentations
• Close collaboration with the Quality team to align on concept and proper application of existing quality systems and support their development
• Providing active support to colleagues in implementing requirements and translate them into solutions

Your expertise

• Degree (Bachelor, Master, PhD) in the field of natural science, biotechnology or comparable
• Solid quality background, specifically with core GxP systems like Change Control, Deviation Management, CAPA
• Professional experience in quality or regulatory in manufacturing pharma industry, CMO/CDO/CDMO companies or in industry developing, manufacturing, and marketing of equipment for use in pharmaceutical manufacturing
• Professional experience with specific quality tools used in pharmaceutical industry like:

Computer software validation (CSV) based on the principles of e.g. 21CFR11,

Equipment qualification (IQ/OQ) Eurdalex Vol 4 Annex 15,

Process Validation,

Extractable / Leachable data generation and evaluation,

Critical impurities and contact material compliance (e.g. TSE)

• Excellent communication skills in German and English in spoken and writing
• Accurate and detail-oriented mindset
• Highly skilled in standard Microsoft Office applications
• Passionate and motivating attitude

Your benefits at Eppendorf

• Your work is meaningful. Together we contribute to improve human living conditions.
• We offer you creative freedom with a strong, international premium brand in the life science industry.
• Thirty vacation days per year and company-regulated special leave days are a given with us.
• With our flexible flextime framework and a working time account, you can plan your working hours individually and independently create a balanced work-life balance.
• We also offer you the opportunity to work remotely across Germany for part of your working time, tailored to suit your life situation.
• We provide you with a variety of social benefits, such as additional employer-funded retirement plans, a job bike, public transport subsidies, corporate benefits, etc.
• To deepen your knowledge and continuously develop professionally and personally, we offer you a wide range of freely selectable training sessions, participation in conferences, and access to learning platforms.
• With us, you will find a diverse, open-minded, and appreciative work environment with the latest technologies, methods, and tools in a set