Proclinical are recruiting a Regulatory Affairs Manager / Clinical Trial Applications for a global pharmaceutical organisation on a permanent basis and is located in Frankfurt.
Responsibilities:
- Responsible for supporting the conduct of sponsored clinical trials of our R&D team to ensure adequate quality and meet regulatory and legal requirements.
- Developing of regulatory strategies for planned Clinical Trials (Clinical Trials phases I-IV with IMP)
- Preparing of regulatory documents for sponsored Clinical Trials, overseeing submissions of CTAs to regulatory authorities and ethics committees, management, and follow-up of CTAs in cross-functional cooperation and service providers.
- Supporting of service provider selection for Clinical Trials and management for regulatory aspects, participation in Clinical Trial Team meetings and specific external meetings (e.g., Investigator Meetings, meetings with regulatory authorities/ethics committees)
- Preparation and coordination of specific chapters of the product dossier (e.g., Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND)
- Providing regulatory documents for the eTMF to ensure readiness for audit/inspection during the Clinical Trial and for long-term archiving.
- Conduct and review of entries in Clinical Trial Registries (e.g., EudraCT) to ensure compliance with regulatory requirements.
Key Skills and Requirements:
- University degree in life sciences or medical health or other equivalent professional qualifications
- Comprehensive Experiences as Regulatory Affairs Manager as well as experiences in Clinical Trial processes
- Advanced knowledge in clinical research and in the conduct of clinical trials and regarding relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)
- Professional verbal and written communication and great presentation skills
- Advanced knowledge of medical or scientific terminology
- Fluent communication skills (business) English
- Team-oriented style of working and flexibility and ability to support various clinical trials simultaneously
If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at +49 69589969... [Vollständig anzeigen] 69.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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