Regulatory Affairs Officer

Renown Pharmaceutical Pvt Ltd

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

• Experience

  0 - 2 Years

• No. of Openings

  3

• Education

  B.Pharma, M.Pharma

• Role

  Regulatory Affairs Officer

• Industry Type

  Hospitals / Medical / Healthcare Equipments

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office