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Regulatory Affairs Associate I

3.00 to 5.00 Years   Mumbai City   29 Sep, 2020
Watson Pharma Private Limited
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • Prepare,compile,review and submit high quality submissions for all required post-approval activities in accordance with European,Australian & Brazilian legislation and in-house standards.
  • Ensure approvals are secured within stipulated timelines and maintain registration documentation and associated electronic databases,in line with in-house procedures.
  • Provide regulatory support and product information for all internal and external customers,stakeholders and Teva project teams.
  • Priorities,plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
  • Communicate with other Teva departments and adhoc needs at the direction of senior regulatory affairs personnel.
  • To complete the aasigned tasks for new MA approvals and post-approval activities in accordance with the work instructions to achieve regulatory compliance.
  • Ensure task completion within the stipulated timeslines for designated projects.
  • Provide regulatory support for EU and growth markets.
Qualifications
  • Required 3-5 years of relevant experience.
  • Candidate should be M.Pharm/B.Pharm/MSC graduate.
,

Keyskills :
clinical trialsdocumentationapacdcgisoptask completionwork instructionsregulatory affairselectronic databasesregulatory compliancelegislative relationspharmaresearchapprovalsdatabasesnetworkingcomplianceinvestment

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