Associate Director responsible for overseeing GMP compliance audits in Global Quality Technical and Compliance Team at Animal Health sites. Focused on ensuring regulatory compliance and effective audit program management in the pharmaceutical industry.
TK
Hybrid Regulatory Affairs Manager – Focus on Biosimilars
Posted 2 months ago
About the role
- Regulatory Affairs Manager implementing global regulatory guidelines for biopharmaceutical products. Managing documents and changes while coordinating with international teams for compliance.
Responsibilities
- Implement global regulatory requirements at the national level in close coordination with international Regulatory Affairs teams
- Prepare, review and maintain regulatory submission documents
- Maintain external portals (e.g., medicinal product listings and information services)
- Support artwork changes and implement regulatory updates throughout the product lifecycle
- Stay up to date on regulatory developments and communicate relevant information to internal stakeholders
- Ensure traceable documentation within the existing document management system (DMS)
Requirements
- University degree (natural sciences, pharmacy, or equivalent)
- Professional experience in Regulatory Affairs for human medicinal products
- Ideally experience with centralized authorization procedures and international interfaces
- Fluent German (C1) and good English skills
- Structured and meticulous working style
Benefits
- Attractive salary and comprehensive additional benefits (e.g., pension plan)
- Flexible working hours and 2 days remote work per week
- Extensive training and development opportunities
- Job ticket, company bike (JobRad), and more
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Electric Compliance and Risk Consultant providing oversight of NERC Planning standards within Electric Engineering operations. Collaborating with various business units to ensure regulatory compliance and improve internal controls.
Expert Analyst enhancing compliance program for PG&E's electric operations. Providing guidance, tools, and testing for risk and compliance initiatives.
Expert Compliance & Risk Consultant collaborating with engineering and operations for NERC compliance oversight. Supporting mitigation plans and developing internal controls within utility regulatory framework.
Senior management role overseeing technology compliance and risk management initiatives across wealth technology in India. Collaborating with stakeholders, and ensuring robust controls and compliance measures are in place.
International Regulatory Affairs Senior Specialist advancing global market access by providing technical support to ensure compliance for medical devices. Focused on facilitating registrations, renewals, and quality approvals.
Staff Quality Engineer leading quality compliance and process improvements at PROCEPT BioRobotics. Ensuring regulatory compliance and enhancing quality metrics in surgical robotics.
Analista de Compliance Júnior realizando análises de Due Diligence. Fortalecendo a ética e conformidade no ambiente corporativo.
Assistente de Compliance supporting integrity program activities like Due Diligence and investigations at compliance team. Ensuring adherence to internal policies and legal regulations.
Compliance Coordinator overseeing integrity program and corporate compliance at Renner. Leading audits, managing reports, and coordinating ethical culture initiatives.