Regulatory Affairs Officer

Vor 5 Tagen

Munich, Deutschland Linical Europe Vollzeit

**Linical Co.**, Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe

**Role Summary**:
The main responsibility of a RAO is to perform Regulatory and ethics submission in a particular country. Experience with German and Czech Republic submissions is desirable.

**Description of the tasks / routine work**:

- Ensures completeness and accuracy of the CA/EC submission packages.
- Ensures regulatory submission deadlines are met.
- Acts as liaison with regulatory agencies to request information and resolve any questions or issues.
- Provides ongoing support to project teams as regulatory designee for all activities during the life cycle of a clinical study.
- Contributes to process improvement initiatives.
- Performs all RAO’s tasks specified in SOPs for the local office location or delegate such tasks to suitably trained personnel.
- Participates in relevant job-related trainings.
- Collaborates with Regulatory Affairs Team, Clinical Operations Team, and Quality Assurance Department.
- Performs any other job-related tasks assigned by the functional superior.

**Education & Qualifications**:
University degree (e.g., PhD or Master, or Bachelor), and basic knowledge in the conduct of clinical trials and non-interventional studies.

Preferred experience in local Regulatory submissions or clinical operations department (CRO or Pharmaceutical company).

At least a basic understanding of European regulations, ICH GCP and any further applicable regulatory requirements and legislation governing a conduct of clinical research in the corresponding country/ Linical office

**Personal skills**:

- Ability to prioritize and manage multiple tasks.
- Good communications and presentation skills.
- Very good organizational and problem-solving skills.
- Knowledge in the conduct of clinical trials, non-interventional studies and the corresponding regulatory requirements/procedures.
- Equal opportunities employer:_

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