
Regulatory Affairs- EU Market
2 weeks ago
Greetings of the day
Our reputed MNC Client is hiring for:
Designation: Regulatory Affairs- EU Market- Pre & Post Approval
Location: Hyderabad
Shift: General
Work Mode: WFO (5 days working)
Interview Mode: F2F interview
NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation
Role & responsibilities:
Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module
Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines)
Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development along with general analytical aspects) for effective review of R&;D documents
Should be aware of post approval variation requirements in EU markets. Should have basic QA knowledge to enable correct review of plant related documents
Key specifications/ Work exposure
- Core Europe Experience in M2, M3 within pharma industry & RA formulations
- FRD/FARD/QA Experience + Minimum 1 yrs of Exp in Regulatory Europe(EU) market.
Warm Regards,
Gayatri Kumari
Email Id:
V3 Staffing Solutions
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