Regulatory Specialist
vor 17 Stunden
**Job summary**:
As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in Germany. Reporting to **Clinical Operations Manager**, you will be a key member of the Clinical Operations team in the country.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward submissions and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
**Main Tasks of the Position**:
- Participates in all activities that lead to start up of investigational sites
- Takes part in the communication with Regulatory Authorities and Ethics Committees
- Interacts with Customers when receiving requirements from Regulatory Authorities
- Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures
- Provides training and support to CRAs in order to collect all necessarily documents for start up package and IP release
- Close collaboration with Regulatory Lead and Project Team during entire project
**Required Qualifications, Experience, Competencies**
- Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
- Open to learn and develop
- Excellent organizational and time management skills
- Skills to handle multiple priorities and to work with deadlines and under pressure
- Excellent written and oral communication skills
- Fluent in written and verbal English and German
- Computer skill
**Benefits**:
- Working with experienced and very professional and supportive team
- Possibility to grow within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme
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