Regulatory submission of new products, variations, response to queries, Life cycle management for WHO & Sub Sahara Africa markets through preparation of quality dossiers enabling timely approvals.
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.
Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
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
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.
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues.
At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come.
With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
