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require Regulatory affairs associate

4.00 to 6.00 Years   Chennai, Hyderabad, Kolkata, Delhi   04 Aug, 2022
PAREXEL International
Job LocationChennai, Hyderabad, Kolkata, Delhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries . Experience with ROW countries would be a plus.Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.Liaise closely with cross-functional members with aligned product responsibilities.Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable)Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documentsPrior working experience in Regulatory Information Management Systems like Veeva Vault would be desirableQualificationsBachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences#LI-REMOTE,

Keyskills :
clinical trialsdocumentationapacdcgisopmanagement systemlegislative relationsinformation managementichveevavaultplanningauthoringmanagementregulatorymaintenancepreparation

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