Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5 billion. Supported by more than 40+ manufacturing facilities, SUN provides high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
Sun Pharmaceutical Industries Limited – Baroda
We invite applications for opening in Drug Regulatory Affairs – (Market : Asian, Brazil and LATAM)
- Grade : Sr Executive / Manager
- Qualification : M.Pharm
- Location : Baroda
Brief JD :
Regulatory submission of new products, variations, response to queries, Life cycle management for Asea, Brazil including other LATAM countries through preparation of quality dossiers enabling timely approvals.Area Of Responsibility:
1. New submissions:
a. Review & prepare CMC (Chemistry, Manufacturing and Controls) 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 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 stake holders upon receipt of approval and update the
same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.
Send in your resume to: [email protected]
Freshers need not apply
