Team Member- FDA LL Unit

The primary objective of the role is to facilitate timely approvals from FDA (Loan License units) by effectively collaborating with internal stakeholders and FDA teams to submit various applications. It also involves establishing strong relationships with external stakeholders and engaging in advocacy efforts to support licensing approvals for Cipla LL products. Responsibilities include: - Ensuring timely Regulatory Approvals from State FDA and CDSCO offices for loan license units by following up and obtaining approvals for various applications such as fresh loan licenses, Additional product permissions, Test Licenses, India Business Tender Certificates, WHO-GMP, COPP, State FDA NOC for new drugs, CDSCO applications, etc. - Strategizing and coordinating with internal stakeholders to ensure timely application submissions and resolution of queries and approvals. - Maintaining a master tracker list of all permissions/approvals of FDA (LL) team. - Coordinating with internal cross-functional teams for necessary documentation required for application filing. - Overseeing and checking the work done by LL team members. - Building and maintaining relationships with external stakeholders (FDA/CDSCO). - Monitoring and tracking timely release of CMCL for local and export markets. - Ensuring compliance with regulatory requirements and pharmacopeial changes. - Addressing major challenges such as obtaining India Business Tender Certificates, Test Licenses, and timely FDA permissions and label artwork approvals to support Tech transfer activities at loan license units. Key Interactions: - QA Departments - R&D Department - FDA coordination team - Regulatory Affairs - Deputy Drug Controller CDSCO - Assistant Drug Controller - Assistant Drug Inspectors - Drugs Inspectors The role requires a candidate with a B.Sc. / B.Pharm qualification, 5-10 years of experience in the pharmaceutical industry, good coordination, and communication skills, as well as regulatory experience with FDA and CDSCO online applications. Key decisions include strategizing for key license approvals in consultation with the Reporting manager, decisions related to various FDA/CDSCO applications and submissions at state FDA/CDSCO offices, and artwork approvals of new products. The role also involves monitoring and implementing regulatory and pharmacopeial upgradations to ensure compliance and avoid non-compliance issues. Overall, the position plays a crucial role in ensuring the smooth and timely approval process for loan license units and maintaining positive relationships with both internal and external stakeholders.,