Regulatory Affairs Manager
A biotechnology company in Frankfurt are looking for a bright and talented Regulatory Affairs Manager to assist with clinical projects. The individual will be able to step up and help the organisation make life changing improvements to medicine.
- Provide responses to regulatory agencies regarding product information or issues
- Train staff in regulatory policies or procedures
- Manage activities such as audits, regulatory agency inspections, or product recalls
- Participate in the development or implementation of clinical trial protocols
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Communicate regulatory information to multiple departments
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives
Skills and Requirements
- Degree in life science, medicine or pharmacy
- Min. 2 years of experience in pharmaceutical environment
- Very good command of English (both oral and written), as well as German
- Thorough knowledge of guidelines
- Problem-solving skills
- Self-driven and structured/organized
- Strong presentation skills
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nico Kohlwes on +49 69 94189257 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.