Job title: Associate-Regulatory Affairs

Company: Sanofi

Job description: Authoring of dossiers andPreparation of queryresponse,Databaseupdate, Working one-tools * Authoring of regulatory dossier:Ensurethatalldatasupplied to theaffiliates/regulatoryauthoritiesareof the highest quality possible interms of both content an

Authoring of dossiers andPreparation of queryresponse,Databaseupdate, Working one-tools Authoring of regulatory dossier:Ensurethatalldatasupplied to theaffiliates/regulatoryauthoritiesareof the highest quality possible interms of both content and presentation, whilst meeting agreed deadlines. Workproactivelywithinternalstakeholders to ensureprojectneedsaremetcompliantlywithinagreedtimelines. Assistandprovidesupportin the preparation,distributionandfollowupofregistrationdocumentationrequired to affiliates/ regulatory authorities. Proper utilisation of regulatorye-tools. Provide support transversely. Maintain and update all the relevant databasesup-to-date. Review of artworks as per the labelling requirements. Self-Development andOtherexpectations ParticipatesandCoordinatewithcrossfunctionalteamsforgatheringtherequiredinformation/documentsrequired for authoring thedossiers and query response. SupportsSiteRSO/RPMswithregard Regulatory Gap assessments. Supports Site projectteamsandexternalstakeholders as partof project execution. EnsureclosecollaborationwithQualityandProcessImprovementteams to ensureoptimalprocessesandtoolsaredevelopedandimplemented.LeadcreationandrevisionofrelevantSOPsandworkinstructions. Evaluate and improveprocessesforsubmissionsand regulatoryinformation. Understanding ofChange controls. Act as a Teammember. Active participation in meeting the targets. To update the knowledge from time to time for effective delivery. Follow up with cross functional teams, ensure the target timelines are met. Handle requests, either internal or external, related to RA activities. Knowledge, Skills & Competencies / Language Ability to work in the teams and Multi-tasking ability. Demonstratedcapacitytotake up additionaltasks. Working knowledge of CMC/technical writing skills. Knowledge ofRegulatory guidance. English communication proficiency, both oraland written. Candidate should have excellentinterpersonal skills, be a self-driven proactive individual with skills inorganization, building working relationships and communication. Basic software knowledge (Microsoft windows etc.) is must. Experience of handing regulatory tools would be an advantage. Requirements of the job This position requiresthroughknowledge onVaccinesmanufacturing/testing. This position requires the incumbent to be proactive in meetingthe organization needs Thispositionwillsuit an individualwhoisable to operate with discretionandconfidentialityaboutsensitive data To comply withHSE compliance and Business Ethicsthroughout the job Qualification Graduate/Post Graduate in Lifesciences, Pharmacy Minimum1-6years’experiencewithinRegulatoryAffairsorinsimilarfunctionintheVaccineor Biological industrywith CMCandIndustrialOperationsexperience is preferred. Demonstrated experiencesin international and local regulatoryaffairs on Vaccines or Biological products. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Expected salary:

Location: India

Job date: Sun, 03 Jul 2022 22:48:20 GMT

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