Department Details
Role Summary
- Hands on experience on preparation, review and submission of ANDA / ANDS in US / Canada market, including Module 1.
- Experience and knowledge on life cycle management for the products filed in US / Canada.
- Documentations required for dossier submission.
- Knowledge on regulatory guidelines / requirements
Key Responsibilities
Hands on experience on preparation, review and submission of ANDA / ANDS in US / Canada market, including Module 1.Experience and knowledge on life cycle management for the products filed in US / Canada.Review of technical (developmental and plant) documentations required for dossier submission.Comprehensive and up-to-date knowledge on regulatory guidelines / requirements.Providing necessary regulatory inputs to different cross functional teams during different stages of product development and manufacturing.Educational Qualifications
Required Education Qualification :
Required Experience : 6 - 10 years