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Regulatory Affairs Consultant

3.00 to 6.00 Years   Bangalore   18 Jan, 2021
Job LocationBangalore
EducationNot Mentioned
SalaryRs 3.0 - 4.5 Lakh/Yr
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Expertise in CTD / eCTD submissions as well as Post Approval Activities: Licence Renewal, Variations etc for Regulated as well as Semi regulated markets.Well versed with Site Transfers, MA Transfers and related activities (especially for EU and US regions).Must able to handle Health Authority Query Responses as well as Gap Analysis prior submissions, Change Control management etc. from RA perspective.Exhibits good project management skills. Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomesTypically works within a team environment but may work independently delivering services within their technical area of expertiseProactively assesses client needs and develops processes and solutions to address issuesExcellent interpersonal and intercultural communication skills, both written and verbalQualificationsB.Pharm, M.Pharm or any life sciences related discipline,

Keyskills :
gap analysislife scienceschange controlproject managementcommunication skillsintercultural communicationctdstepscontrolanalysismanagementcommunicationinterculturalGenomicsgap

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