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Regulatory Affairs executive

2.00 to 7.00 Years   Mumbai City   15 Apr, 2021
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD,Corporate Legal Department
EmploymentTypeFull-time

Job Description

-

  • Ensuring preparing & submission of Dossiers for Product registration for local and export.
  • Handling local FDA, DCGI requirements.
  • Ensure accuracy, completeness and quality of regulatory submissions.
  • Ensuring accurate and timely responses to queries from internal and external customers.
  • Carrying out any task delegated by Export Manager which contributes to overall running of the Export Department and assisting Export Manager in marketing & business development activities.

Candidate Criteria:-

  • B.pharm/B.sc qualified with minimum 2 years of experience in regulatory affairs from pharmaceutical formulation background.
  • Good knowledge of ICH, WHO, and regulated market
  • Should be a permanent resident from Mumbai & have accommodation here.
  • Should have a strong command over written & verbal communication in English.
,

Keyskills :
regulatory affairsbusiness developmentverbal communicationproduct registrationichdcgipharmarunningcommandbusinessmarketingregulatoryformulationregistrationcommunicationElectronic Common Technical DocumentRegulatory SubmissionsAbbreviated

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