Job Description

Division
Corporate Affairs
Department
Corporate
Sub Department 1
Job Purpose
To 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 products
Key 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 rules
Key Accountabilities (4/6)
Compliance by monitoring the upgradation in Regulatory requirements and pharmacopeial changes
Track 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 Affairs
Key Interactions (2/2)
Deputy Drug Controller CDSCO, Assistant Drug Controller, Assistant Drug Inspectors, Drugs Inspectors
Dimensions (1/2)
Timely approvals for LL locations
Dimensions (2/2)
Key Decisions (1/2)
Decisions pertaining to various FDA/CDSCO applications and submissions at state FDA/CDSCO office, artwork approvals of new products
Key Decisions (2/2)
Strategizing for key license approvals in consultation with Reporting manager as and when required
Education Qualification
Educational qualifications:
B.Sc. / B.Pharm
Threshold skills and capabilities required to execute the role
Good co-ordination and communication skill
Regulatory Experience
Well versed with FDA and CDSCO online applications xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9xc3xa2xc3x82xc2x82xc2xacxc3xa2xc3x82xc2x80xc2xb9
Relevant Work Experience
5-10 yearsxc3xa2xc3x82xc2x84xc2xa2 experience in pharmaceutical industry.