Sun Pharmaceutical Industries Ltd Job Vacancy for Regulatory Affairs
Experience: 2-5 years
Qualification: M.Pharm
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. Review regulatory filing impact of variations, change controls, etc.
Send in your resume to: Rosemary.varghese@sunpharma.com
Note- Sun Pharma does not seek payment of any kind from a prospective candidates for employment with Sun Pharma or authorize any agency or any individual to collect or charge any fees or charges for recruitment.
Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun Pharma.
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