Regulatory Support

1 month ago


Ridge, United States Magicforce Full time
  • experiencein pharmaceuticalenvironment.
  • Experiencein regulatory environment isrequired.
  • Highlevel exposure or knowledge about FDA inspection and internal auditprocess.
  • Knowledgeor exposure on Veeva RIM Submission/Archive Publishingetc.

JobTitle:Consultant

Qualifications:

  • Bachelorsdegree preferably in a life science or a related field
  • 5to 10 years of experience in pharmaceuticalenvironment.
  • Experiencein regulatory environment isrequired.
  • Excellentwritten verbal communication and presentationskills.
  • Highlevel exposure or knowledge about FDA inspection and internal auditprocess.
  • Knowledgeor exposure on Veeva RIM Submission/Archive Publishingetc.

JDdetails:

  • Ensurecompliance with company Standard Operating Procedures andregulatory agencyregulations/guidance.
  • RepresentsRegulatory Affairs on crossfunctional project teams.
  • Providetechnical expertise to crossfunctional teams on managing thelifecycle of submissionrelateddocuments.
  • Workwith Veeva Submissions/Archive team subject matter experts andcross functional departments to support businessneeds.
  • Effectivelycommunicate and work collaboratively with crossfunctional teamsincluding regulatory affairs clinical operations and qualityassurance &validation.
  • Gatherand assemble information necessary for submissions in accordancewithregulations/guidance.
  • Capableof reviewing documentation with a high degree of attention todetail. Proactive to identify issues and propose solutions asnecessary.
  • Conductreview of published submissions to ensure consistency andcompliance with regulatoryrequirements.
  • Maintainknowledge of local and global regulatory submissionrequirements.
  • Maintaincompliance with GxP government regulations industry standardsapproved specifications and Company procedures&directives.
  • ProvideRegulatory Affairs support during internal and external audits andinspections.
  • Exposurein Change management process requirement gathering qualifying thechangesetc.
  • Activelyparticipate in the development of Regulatory Operations processeslike SOPs/GOPs Work instructions Checklist templatesetc.
  • Consistentlysupport for regulatory systems access and changemanagement.
  • Responsiblefor communicating business process improvements business relatedissues status updates oropportunities.

Veeva,pharmaceutical


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