Research Scientist
SUN PHARMA
Vadodara, Gujarat, India
Over 200 applicants
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Job Summary
Regulatory submission of new products, variations, response to queries and Life cycle management for Nepal and Myanmar
markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
Regulatory submission of new products, variations, response to queries and Life cycle management for Nepal and Myanmar
markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
- New submissions:
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Review documents (Development report, scale up report, specification, stability protocol), artworks etc.
- Approval :
- Lifecycle management for drug formulations:
- Prepare and review variations as per the country specific requirements to support approval of changes such as API
- Regulatory compliance:
- Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and update
- Ensure reposition of comprehensive product information into central repository
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Other -
Industries
Pharmaceutical Manufacturing
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