Freyr Solutions
Location
Hyderabad | India
Job description
Product Portfolio: Innovator & Biological Products - Markets ( EU ,US ,ROW) Experience: Change Control Assessment Preparation of Regulatory Submission Strategy Preparation and review of Variation/post approval submission packages Grouping and Work sharing experience Preparation and review of Annual Reports for NDAs, BLAs, INDs Preparation and Review of Renewals for MAAs Types of changes: DP manufacturing site transfers API manufacturing site transfers Packaging site changes Analytical testing site changes Administrative changes
Job tags
Salary
