Personal Information
Organization / Workplace
Mumbai Area, India India
Occupation
Senior Manager - Regulatory Affairs
Industry
Technology / Software / Internet
About
Regulatory Submissions Publishing for US, EU, CAN and other ROW regions. Process Advice/Implementation:
- eCTD/NeeS/Paper Submissions Publishing
- CTD Document Template Creation
- Cross-Line Process Advice/Implementation
- Conducting Trainings and Knowledge Transfer sessions on Electronic submissions (eCTD/NeeS)
- Planning, organising and managing day-to-day activities of the project
- Negotiating new projects transition
- Resource management
- Production of Comprehensive and Easy-to-Follow SOPs, Work Instructions, Training Guides etc.,
Specialties:CTD, eCTD, NeeS, Publishing, Process Advice, Process Implementation, Regulatory Operations
Software skills: eCTDXpress v3.2.3, ISIPublish...
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