Responsibilities
- Ensure change management, post approval changes to ANVISA
- Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP).
- Writing PATE for post approval changes
- Respond to technical deficiencies received from ANVISA
- Maintain department records as assigned.
- Application for Good Manufacturing Practices to ANVISA
- Coordination of Pharmaceutical and Analytical Testing laboratory and Clinical Research Organization for PE and BE studies.
- Coordination with ANVISA for technical queries
Desired Skills
- Complete knowledge of ANVISA regulatory guidance
- Proficient in new product submissions for solid oral dosages, parental/sterile formulations to ANVISA
- Reading/Writing Portugal language preferred or willing to learn the language.
4+ years experience
Email: nandini.singh@unichemlabs.com, hrgoa@unichemlabs.com
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