Regulatory Affairs Associate (w/m) (Germany)Shared Work – Shared Vision: The way we do business, a promised standard that includes ongoing support from a specialized team dedicated to meeting or exceeding our clients expectations.
- Preparation and coordination of the submission of Clinical Trial Applications, including local submission procedures and local Regulatory requirements
- Compilation and review of all documents required for the submission to the Ethics Committee and Institutional Review Boards
- Submission of all relevant study documents to EC/IRB, CA, local authorities and institutions.
- Preparation of core dossiers for other affiliates or subcontractors for submissions in other countries
- Ensuring that clinical trials applications are conducted according to local and international requirements/procedures (ICH-GCP, applicable local law and guidelines, applicable SOPs)
- Responsibility for the notification of sites to local authorities and for end of clinical trial notifications
- Assistance with regulatory intelligence by monitoring the global regulatory environment and providing regulatory summaries
- Collaboration with Clinical Operations and other internal departments if needed
- Bachelor's degree in business, life sciences or a related field of study
- Regulatory Affairs experience in a CRO or the pharmaceutical industry
- Strong understanding and knowledge of local requirements of Ethics Committees and Competent Authorities submission procedures according to international and national laws and guidelines
- Proficiency in MS Office and regulatory databases
- Effective verbal and writing skills (English)