Sun Pharmaceutical Industries Ltd
Designation : Executive
Function : Regulatory Affairs
Functional Area : RA-MENA, South Africa
Job Role Summary : Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.
Job Profile :
- New submissions/Renewals:
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
- Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
- Lifecycle management for drug formulations:
- Prepare and review variations as per the country specific requirements to support approval of changes such as API, vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
- Regulatory compliance:
- Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and updatethe same based on queries and variations.
- Â Review regulatory filing impact of variations, change controls, etc.
Job Requirements :
- Experience Tenure: 1-4 years
- Pharma formulations regulatory experience
Work / Job Experience : 1-4 Years
Type of Experience : Pharma Formulations CMC compilation, life cycle management
Academic Qualifications :
M.Sc /M.Pharm
