skillindiajobs
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Regulatory Affairs Associate I

3.00 to 6.00 Years   Mumbai City   29 Sep, 2020
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Roles Responsibilities:

  • Change control assessments for EU other international markets
  • Completing initial RA assessment in GCCM trackwise
  • Creating regulatory submission task
  • Co-ordinating with Canada site RA,cross functional team and submission RA and finalization of change classification.
  • Compilation of variation package and providing to submission RA
  • Compilation of US Annual report package for Canada site
  • Intimating to the respective sites for supporting documents after receipt of day 0 mail
  • Reviewing the documents
  • Preparing of tracked changes copy of index from previous annual report.
  • Finalizing the AR package and dispatching to submission RA within 30 days of receipt.
  • Preperation and submission of ANDA product monograph update to health canada
  • Updating the product monograph for canadian products as per the canadian reference product within 30 working days.
Qualifications
  • 3-6 years of relevant experience with MSC/BSC/M.Pharm/B.Pharm as an education
Function Regulatory Affairs Sub Function Medical Regulatory Affairs ,

Keyskills :
apacregulatory affairsdocumentationsopcontrolandapharmatrackwiseresearchdcgichange controlmailnetworkingclinical trialsinvestment researcheducationmedical

Regulatory Affairs Associate I Related Jobs

© 2020 Skillindia All Rights Reserved