Regulatory Affairs

Regulatory Affairs Assistant Manager professional:Core KeywordsRegulatory Affairs (RA)Assistant Manager Regulatory AffairsDossier & Submission ExpertiseCTD / ACTD / eCTD dossier preparationModule 3, Module 5Lifecycle management (PLCM)Post-approval variations / renewalsRegulatory submissions & query responsesClient due diligenceMinistry of Health (MOH)...

Hi Everyone, I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai. Please refer below JD and share your profile on pallavi.ag@peoplefy.com - Experienced in preparing, review and compile regulatory submissions. - Maintain compliance with US FDA and ICH requirements. - Should have experienced in...

Assist in the preparation and submission of regulatory documents to health authorities (e.g., FDA, EMA, CDSCO).Support in maintaining regulatory databases, tracking submissions, and approvals.Ensure compliance with applicable regulations, guidelines, and company SOPs.Help prepare product registration dossiers, variations, renewals, and post-approval...

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing...

Assist in the preparation and submission of regulatory documents to health authorities (e.g., FDA, EMA, CDSCO). - Support in maintaining regulatory databases, tracking submissions, and approvals. - Ensure compliance with applicable regulations, guidelines, and company SOPs. - Help prepare product registration dossiers, variations, renewals, and post-approval...

Job Description JOB Responsibility - Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products - Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO - Preparation, review & submission of techpack as per...

Key Responsibilities : Regulatory affairs and liaisingProcurement and purchasingFacilities administration and managementPersonnel managementProject managementInfrastructure maintenanceDevelopment of organizational policies related to facilities management and purchasingManaging administrative budgets and controlling expensesFormulating policies for hiring,...

Collect, review, and process adverse event reports from healthcare professionals, patients, and clinical studies.Enter and maintain accurate case data in safety databases.Perform case assessment and narrative writing under supervision.Assist in the preparation of Individual Case Safety Reports (ICSRs) and follow-up activities.Support signal detection and...

Lead government-sector business development initiatives. Secure government contracts, manage compliance, and build relationships with public sector entities. Prior experience in government tenders and regulatory frameworks is required. Key Responsibilities:Drive business development initiatives targeting government clients, including Central and State...

Quality Assurance, Quality Control, Clinical Research , Regulatory Affairs, Medical Record Summerization , Medical Claims , Medical Officer, Medical Billing , Pharmacist, ADL, ARD, FRD, CDM, Production, R&D , Lab Technician