Ind-Swift Laboratories Ltd. is the fastest growing API Group. We are having 6 + API Manufacturing Facilities across the globe. We are dealing in regulated market having approvals like USFDA, MHRA, TGA.
Post : Executive / Sr. Executive - Drug Regulatory Affairs (api)
Job Description
- To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirements.
- To write, check/review of documents as per regulatory requirements
- To publish with software submission documentation as per regulatory requirements
- To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
- To support local in-licensing
- To collaborate with other departments/partners
- To maintain lists/documents/records
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating.
Additional Information:
Experience : 3 - 7 Years
Location: Chandigarh
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug Regulatory Affairs/Documentation
Role: Documentation/Medical Writing
Employment Type: Permanent Job, Full Time
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