Team Member- Fda Ll Unit

DivisionCorporate AffairsDepartmentCorporateSub Department 1Job PurposeTo ensure timely approvals from FDA Loan License units by seamlessly coordinating with internal stakeholders and FDA teams for submission of various applications Develop good relationship with concerned external stakeholders and undertake advocacy to support licensing approvals for Cipla LL productsKey Accountabilities 1 6 Timely Regulatory Approvals from State FDA and CDSCO offices for loan license units To follow up and obtain timely approvals of various applications viz fresh loan licenses Additional product permissions Test Licenses India Business Tender Certificates WHO-GMP COPP etc State FDA NOC for new drugs etc CDSCO applications viz Test license NOC Written Confirmation Applications WHO-GMP COPP etc Strategizing and co-ordination with internal stakeholders to ensure timely applications and resolution of queries and approvals Owner for the master tracker list of all permissions approvals of FDA LL team Coordinate with internal cross-functional teams for necessary documentation required for application filing To oversee and check the work done by LL team members Coordination with FDA liaising team for application filings and approvals from FDA Key Accountabilities 2 6 Building relationship with external stakeholder FDA CDSCO Build and maintain regular engagement rhythm with relevant stakeholder in FDA and CDSCO offices Key Accountabilities 3 6 Checking monitoring and tracking timely release of CMCL for local and export markets Checking copy matter checklist list CMCL Approval of Packaging Labels as per new regulatory notifications circulars D C act labelling rulesKey Accountabilities 4 6 Compliance by monitoring the upgradation in Regulatory requirements and pharmacopeial changesTrack and monitor on timely basis the implementation of regulatory and pharmacopeial upgradations on labelling matters and FDA licenses through continuous monitoring to avoid non-compliance Key Accountabilities 5 6 Key Accountabilities 6 6 Major Challenges India Business Tender Certificates requirements to obtain the certificates on high priority Test License to be obtain for timely execution of R D batches Obtaining on time FDA permissions and on time label artwork approvals to support Tech transfer team for effective implementation of Tech transfer activity at loan license units Key Interactions 1 2 QA Departments R D Department FDA coordination team Regulatory AffairsKey Interactions 2 2 Deputy Drug Controller CDSCO Assistant Drug Controller Assistant Drug Inspectors Drugs InspectorsDimensions 1 2 Timely approvals for LL locationsDimensions 2 2 Key Decisions 1 2 Decisions pertaining to various FDA CDSCO applications and submissions at state FDA CDSCO office artwork approvals of new productsKey Decisions 2 2 Strategizing for key license approvals in consultation with Reporting manager as and when requiredEducation QualificationEducational qualifications B Sc B PharmThreshold skills and capabilities required to execute the roleGood co-ordination and communication skillRegulatory ExperienceWell versed with FDA and CDSCO online applications xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9Relevant Work Experience5-10 yearsxc3xa2xc3x82xc2x84xc2xa2 experience in pharmaceutical industry