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