FUNCTIONAL COVERAGERegulatory, Quality & SafetyRecruiting – Executive Search – Training & Development – Outplacement

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

YOU ARE HERE

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
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