Job in Drug Regulatory Affairs as Executive, Sr. Executive at Ind-Swift

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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