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Regulatory Affairs Associate I

3.00 to 6.00 Years   Mumbai City   13 Nov, 2020
Watson Pharma Private Limited
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
  • Exposure in handling initial submissions publishing and transmitting quality submissions to agency.
  • Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
  • Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
  • Hands on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
  • Participate in Global Regulatory Affairs project teams
  • Maintain working knowledge of internal and external publishing standards.
  • Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
  • Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
  • Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems

Qualifications :

  • B. Pharm/M. Pharm/ Master of Life Sciences/M Pharm

Experience:

  • Total years of experience required for the role: 3-6 years with Regulatory Publishing experience in EU and US market

Knowledge and skills:

  • Command over spoken and written English
  • Sensitivity to the cultural diversity of a global organization
,

Keyskills :
clinical trialscreative problem solvingquality controlproject teamssopapaclife sciencesregulatory affairsdcgiadobe acrobatichregulatory submissionsproblem solvingisi toolboxregulatory publishingdigital conversioncultural diversity

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