about company :
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Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past seven decades, we have been developing and manufacturing affordable medicines for patients around the world.
Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.
Being a care-focused, research-driven company, we are committed to complying with the highest ethical standard in clinical research and medical practice. We want to be valued not only for our pharmaceutical products but also for the way we conduct our research and business activities.
We lead our industry in demonstrating the application of cutting-edge research to ethical business practices in producing the alchemy of optimum health outcomes for all.
vacancy details :
Position: Regulatory Affairs
📕 Qualification: M.Pharm
📍 Job Location: Dholka, Gujarat.
💼 Experience: Minimum 7 Years of experience
position Requirement :
· Compilation, review and submission of registration dossiers in the regions of US.
· Handling of regulatory queries/deficiencies.
· Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.
· eCTD software handling for ANDA/IND submission, query response and post approval submission.
· Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.
· Review of Analytical method validation / verification / transfer reports.
· Review of DMF and its notifications.
· Review and approval of Change Controls & Deviations.
· Creation and Maintenance of Regulatory Database for all the submissions.
· Tracking of Regulatory Guidance Documents at the respective websites.
· Imparting training across the team on new guidance documents.
note :
🔍 Interested candidate please share your resume on 📧 disha.bhalani@cadilapharma.com
Apply Now!