Job Title: Sr. Executive Regulatory & Business Continuity - India
Business Unit: R&D1 Regulatory Affairs
Job Grade: G11B
Location: Vadodara
Job Description
- Responsible for all activity related to loan license.
- Filling new loan licence application
- Arrange for timely response to the raised queries
- Filling renewal/retentions within time line.
- To support the joint inspections/ FDA audits for grant of loan licences.
- Responsible for all activity related to manufacturing license for Gujarat location.
- Filling new licence application
- Arrange for timely response to the raised queries
- Filling renewal/retentions within time line.
- To support the joint inspections/ FDA audits for grant of new/retention of manufacturing licences.
- Responsible for all the activity related to WHO-GMP applications for Gujarat locations and loan locations.
- Filling renewal/retention of WHO-GMP certificates.
- Filling addition of new products in existing WHO-GMP certificate
- To support the joint inspections.
- Arrange for compliance submission for the raised observations.
- Responsible for all the activates related to Written Confirmation application.
- Preparation and review of export NOC, Form-29 and CoPP applications for other than Gujarat locations.
- Preparation and review miscellaneous applications (e.g. Free Sale Certificate, Manufacturing and market Standing certificate, narcotic and psychotropic substances destruction certificate etc).
- To extend support to the all plant locations as and when required for the applications submissions and approvals.
Travel Estimate
NA
Job Requirements
Educational Qualification: M.Pharm
Experience: Minimum 8 years of relevant experience
Equal Employment Opportunity Statement
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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