Regulatory Affairs Labeling

Your tasks

• RegulatoryImpactAssessment:EvaluatetheregulatoryimplicationsofchangecontrolsraisedinTrackWiseformedicinalproductsregisteredunderCentralized,MutualRecognition,Decentralized,andNationalProcedures.
• ProductInformationManagement:Createandmaintainproductinformationdocumentation,includingtheCompanyCoreDataSheet(CCDS),ensuringscientificaccuracyandalignmentwithclinicalandregulatoryrequirements.
• HealthAuthoritySubmissions:Prepareandsubmitregulatoryvariations,notifications,andrenewals,ensuringthatdocumentationmeetsapplicablerequirementsandsubmissiontimelines.
• RegulatoryQueryManagement:ReviewandrespondtoHealthAuthorityquestionsrelatedtosubmissions,coordinatingwithrelevantstakeholderstoprovideaccurateandtimelyinformation.
• LabelingCoordination:Managemedicinalproductlabelingupdates,includingtranslations,whilecollaboratingwithinternalteamsandclientstakeholderstoensureconsistencyandcompliance.
• Post-ApprovalActivities:Coordinateandmaintainpost-approvalregulatoryactivitiesinVeevaRegulatoryInformationManagementSystem(RIMS),includingartworkupdatesandassociateddocumentation.
• PlanningandQualityAssurance:Organizesubmissionschedules,monitordeliverablesagainstkeyperformanceindicators(KPIs),andmaintainhighstandardsofaccuracyandregulatorycompliance.
• Cross-FunctionalCollaboration:Workcloselywithregulatoryaffairscolleagues,clinicalexperts,andclientteamstoresolveissues,coordinatedeliverables,andsupportefficientregulatoryoperations.

Requirements

• Education:Bachelor'sdegreeinLifeSciences,Pharmacy,Chemistry,orarelateddiscipline,orequivalentprofessionalexperience.
• ProfessionalExperience:Atleast6yearsofexperienceinregulatoryaffairsorregulatorylabeling,preferablywithinthepharmaceutical,clinicalresearch,orhealthcareindustries.
• RegulatoryKnowledge:Strongunderstandingofmedicinalproductlabelingrequirements,HealthAuthoritysubmissionprocesses,andregulatoryprocedures,includingCentralized,MutualRecognition,Decentralized,andNationalProcedures.
• ClinicalandScientificExpertise:Abilitytoassessclinicalinformationandapplyrelevantknowledgewhenpreparingandupdatingproductinformationdocumentation,particularlytheCCDS.
• TechnicalProficiency:FamiliaritywithVeevaRIMSandTrackWiseforregulatoryinformationmanagement,changecontrolassessment,andpost-approvalactivities.
• PreferredSkills:ExperiencewiththeExtendedEudraVigilanceProductDictionary(xEVMPD)isanadvantage.
• Communication:FluencyinEnglish,withstrongwrittenandverbalcommunicationskillsforpreparingregulatorydocumentationandcoordinatingwithstakeholders.
• PlanningandOrganization:Excellentcoordination,prioritization,andtime-managementskills,withtheabilitytomanagemultiplesubmissionsandmeetdeadlines.
• AttentiontoDetail:Acareful,quality-focusedapproachtoregulatorydocumentation,labelingaccuracy,andcompliancerequirements.
• CollaborationandAdaptability:Aproactive,patient-focusedmindsetandtheabilitytoworkeffectivelywithdiverseteamsandclientstakeholdersinafast-paced,regulatedenvironment.

What we offer

• RemoteWork: Work remotely from India, with opportunities to collaborate with international teams.
• ProfessionalDevelopment: Access to continuous learning opportunities and the chance to deepen expertise in regulatory affairs and medicinal product labeling.
• GlobalExposure: Gain experience working with international regulatory procedures, Health Authorities, and cross-functional stakeholders.
• CareerGrowth: Explore opportunities to broaden your regulatory knowledge and develop your career within a global clinical research environment.
• MeaningfulImpact: Contribute to the accuracy and compliance of medicinal product information, helping healthcare professionals and patients access reliable information about medicines.
• CollaborativeCulture: Work alongside experienced professionals in a team-oriented environment that values flexibility, quality, and shared purpose.

Other

How Jobgether works We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.