Global Regulatory Affairs Specialist for Trials & Compliance

Worldwide; Deutschland; Remote; USD 81,000 - 127,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to plan, organize, and submit regulatory submissions across Germany and Switzerland, coordinating with SAR colleagues to ensure timely delivery. You will review and translate submission documents and perform local QC as needed.

The role requires a degree in life sciences and at least three years in CRO regulatory activities, with fluency in German and good English.

Qualifications

• Degree with a major concentration in medical, biological, physical, health, pharmacy or related science
• Minimum three years of experience in clinical research, site activation and/or regulatory-related function within a CRO
• Strong experience in regulatory process in Germany and Switzerland
• Fluency in German is mandatory; working knowledge of English is required

Responsibilities

• Plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
• May act as a contact point for translation review of submission documents
• Provide local QC of submission dossiers prior to dispatch
• Communicate status and action plans to SAR Lead and project team
• Identify risks and mitigation strategies

Skills

Organizational skills

Planning

Written and verbal communication

Team-oriented

Interpersonal skills

MS-Office proficiency

Education

Degree in medical/biological/physical/health/pharmacy or related science

Tools

MS-Office (Word, Excel, PowerPoint)

Job description

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to plan, organize, and submit regulatory submissions across Germany and Switzerland, coordinating with SAR colleagues to ensure timely delivery. You will review and translate submission documents and perform local QC as needed.

The role requires a degree in life sciences and at least three years in CRO regulatory activities, with fluency in German and good English.