Assistant Regulatory Officer - Pharma

Assistant Regulatory Officer - Pharma

1 Nos.
60909
Full Time
4.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 4.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; M.Pharma - Pharmacy
Job Description:

Duties and Responsibilities :

  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
  • Timely compile materials for license renewals, updates and registrations
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Review labeling and labels for compliance with regulatory requirements
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions
  • Provide the regulatory reviews of customer complaints and define the regulatory re-portability
  • Responsible for timely registration of the facility
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
  • Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
  • Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
  • Salary shall be commensurate to experience and qualification.


Working location shall be around 20 Km from Vadodara and company transport will be available.

Company Profile

Our Client is a reputed pharma company based at Vadodara

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