Sun Pharmaceutical Industries is India’s largest Pharmaceutical company having a presence in above 150 Countries, & 4th Largest Generic Pharma in the world is looking for Executive/Officer for Regulatory submission of new products, variations, and responses to queries for the Asia Pacific (APAC) markets through the preparation of quality dossiers enabling timely approvals.
Area Of Responsibility:
1. New submissions:
a. Review & prepare CMC dossiers for fresh submissions.
b. Review documents (Development report, scale-up report, specification, stability protocol), artworks, etc. before initiation of Exhibit batches for adequacy.
2. Approval :
Review & prepare response to deficiency enabling approval of products filed to the regulatory agency.
3. Lifecycle management for drug formulations:
a. Prepare and review variations as per the country requirements to support approval of changes such as API, vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products, etc.
b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
4. Regulatory compliance:
a. Prepare, Review, and circulate approval package to stakeholders upon receipt of approval and update the same based on queries and variations.
b. Ensure reposition of comprehensive product information into the central repository
C. Review regulatory filing impact of variations, change controls, etc.
Location: Vadodara (Baroda) Gujarat
Qualification: B.Pharma, M.Pharma
Expereince: 1-6 Years