Regulatory Affairs Specialist – German Speaker
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Job Description
Regulatory Affairs Specialist ensuring regulatory compliance and submissions for clinical trials in Germany and Switzerland. Collaborating with internal teams and external regulators while managing documentation.
Responsibilities:
- Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
- May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
- Where required provide local QC of submission dossiers prior to dispatch
- Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
- Identify risks and generate mitigation strategies
- When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers
- Maintain country specific patient information sheet and consent form customization text
- Maintain country specific drug labeling information
- Maintain Country Intelligence Pages
- Be familiar with and comply with SOPs, ICH GCP and applicable regulations
- Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
- Advise the SAR project team about appropriate regulatory strategies
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
- Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department
- Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives
Requirements:
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Strong experience in the regulatory process in Germany AND Switzerland
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
- Fluency in German is a mandatory requirement; working knowledge of English is required.
Benefits:
- Global team events
- Professional development opportunities
- Diverse and inclusive workplace
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