New Drug Approvals and Regulatory support for new product launches, BE NOC for export
"• Timely submission and approval of the products for new drug applications including clinical trials and medical device approvals after due diligence of the dossier
Regular follow-ups, meetings with the ADC, DDC, JDC, and DCGI depending on the requirement on project basis for expediting the review process in order to obtain the fast approvals which in turn will help in meeting the launch timelines of the product
Technical discussion with the officials on a project basis in order to provide clarification about the products, helping us to avoid further queries. This in turn helps us to develop confidence about the product and organization in front of the officials •Keeping the team well informed about the upcoming guidances and developments in the CDSCO office.
Submission and approval of BE NOCs /Amendments - Global support
" • Timely submission of BE NOC applications after reviewing of the documents Regular follow-ups, technical discussions with the ADC, DDC, or JDC ( depending on case to case basis) for early approvals and minimising the queries
To keep the team well informed about the repeated queries and ensure proper documentation in upcoming applications.
Submission of price approvals/ other applications to NPPA
"•Regulatory support to business/finance/supply chain team in regards to filing of Form 1 price approval applications
Review of the documents before submission of the application
Submission and follow-ups including technical discussion whenever required with the NPPA officials
Submission of SAE applications for ongoing clinical trials, discussion with DDC and other officials in regards to any clarifications/queries.
Follow-ups/technical discussion with the regulatory officials pertaining to the submitted Manufacturing & marketing, clinical trial, Export NOC, CLAA endorsement applications, etc.
Submission of samples for IPC testing for new drug approvals
Responsible for submission of samples for testing for new drug approvals
Follow up with the IPC officials for expediting the testing and if required technical discussions on the product and documents done with the officials In order to get the marketing permission within desired timelines
Renewal and fresh Approval of Written confirmation (WC) for all CTO locations
"Submission of fresh and renewal WC applications for all CTO Inhouse Locations to CDSCO Delhi
Follow-ups and discussions with the officials for regulatory approvals to continue manufacturing of products and supply to export
Desired Candidate Profile
Education & Experience
B.Pharm / M.Pharm with relevant experience of 10 - 15 years
In the detailed understanding of Indian regulations, regulatory guidance, and operational/organizational structure of Government regulatory offices
Dr Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics, and Proprietary Products Dr Reddy offer a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations. Major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective. Major markets include India, the USA, Russia-CIS, and Europe apart from other select geographies within Emerging Markets. For more information, log on to www.drreddys.com