Manager 1

SUN PHARMA


Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)

Grade – G12A/G11B

Education – B.Pharm / M. Pharm

Experience – 4 to 6 years

Location – R&D - Baroda

Job Description

  • Review all data and documents related to product registrations for various health authorities.
  • Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
  • Prepare responses to deficiency letters received from various agencies.
  • Maintain life-cycle / post approval changes for drug product registration dossiers.
  • Provide regulatory support to cross functional departments.
  • Prepare and submit scientific advice to various health authorities.
  • eCTD compilation, verification and submission through electronic gateway

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