Executive

Year    Vadodara, Gujarat, India

Job Description


Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)Grade - G12A/G11BEducation - B.Pharm / M. PharmExperience - 4 to 6 yearsLocation - R&D - Baroda:

  • 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
  • Review, preparation and submission of annual reports to US FDA
  • Review, preparation and submission of post approval supplements to US FDA
Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)Grade - G12A/G11BEducation - B.Pharm / M. PharmExperience - 4 to 6 yearsLocation - R&D - Baroda:
  • 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
  • Review, preparation and submission of annual reports to US FDA
  • Review, preparation and submission of post approval supplements to US FDA

Sun Pharmaceutical Industries

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Job Detail

  • Job Id
    JD3448688
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Vadodara, Gujarat, India
  • Education
    Not mentioned
  • Experience
    Year