Punctually listed below, you can find the most typical roles and assignments the ISG-Group is usually recruiting and placing for it’s clients.

Recruiting & Executive Search within

Regulatory, Quality & Safety

• Regulatory Affairs & -Harmonization
• Technical Requirements for Registration of Pharmaceuticals for Human Use
• General Marketing Authorization Communication
• CPMP Communication & -Reporting
• National Submissions Management
• Mutual Recognition Procedures (MRP's)
• EMEA Submissions Management
• FDA/Canada Submissions Management
• E-Regulatory / Electronic Regulatory Submissions
• Type I and II CMC Variations
• Technical Product Sheet Development
• Harmonization of License Renewals
• Harmonization between 2 Regions
• Regulatory Approvals of Products as a Food Supplement in EU/US
• Technical Architecture of Monographic Products
• Regulatory Switch within Device Classes
• OTC Switches
• Analytical Data Validation & Data Development
• Translation of the Product Information (PI)
• Revision of a Patient Information Leaflet
• Regulatory Preparation of Clinical Studies
• Regulatory Renewals in EU Countries
• Modification of Specifications of finished Products
• Pharmacovigilance
• Periodic Safety Update Reports (PSUR)
• Safety Amendments and Monthly Data
• Quality Management
• Quality Assurance
• Clinical Compliance & -Safety