Company: Pharmalex
Position: Senior Specialist/Assistant Manager, Regulatory Affairs (Publishing)
Experience Required: Minimum 4 Years (Publishing)
Job Role
• Create, compile and validate eCTD and NeeS including MAAs, amendments, variations, renewals, etc.
• Life-Cycle Management of approved products (electronic only).
• Editing of documents according to ICH guidelines (Create bookmarks and links, etc.).
• Preparation of presentations, SOPs and Wls for Internal training.
• Training for various software tools
May share resume at vineeta.bisht@phamalex.com
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