Regulatory Affairs

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...

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...

Planning and coordinating with project management team, regulatory affairs, analytical development and management teamPivotal involvement in product pre-formulation study and prototype formulation developmentPreparing reports, compiling/interpreting data and validating stability data of developmental batchesKey role involvement in a vast gamut of activities...

We are looking for a highly motivated and experienced Business Executive to join our team at Eris Lifesciences Limited, a leading biotechnology company in the pharmaceutical industry. The ideal candidate will have a strong background in business development and management, with excellent communication and interpersonal skills.Roles and ResponsibilityDevelop...

Job DescriptionAccountabilities Key Performance IndicatorsMarket the Airport and on board the Airlines, as per the planOnboarding of Dom / Int. airlines as per the Business planPrepare and sign off the Aero Business Plan.In line with the Bid Model.Bid out and appoint the Aero concessionaires (GH, Fuel Farm, Cargo, etc.).Negotiate and Sign off...

Position - Head Administration & FacilitiesInstitute - Leading B SchoolLocation - NagpurKey Responsibilities :Regulatory affairs and liaisingProcurement and purchasingFacilities administration and managementPersonnel managementProject managementInfrastructure maintenanceDevelopment of organizational policies related to facilities management and...

Regulatory Affairs Assistant Manager professional: Core Keywords Regulatory Affairs (RA) Assistant Manager Regulatory Affairs Dossier & Submission Expertise CTD / ACTD / eCTD dossier preparation Module 3, Module 5 Lifecycle management (PLCM) Post-approval variations / renewals Regulatory submissions & query responses Client due diligence Ministry of Health...

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...

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...

**Key Responsibilities**: - **Regulatory Compliance**: - Ensure that the company’s pharmaceutical products comply with all applicable regulations (FDA, CDSCO). - Keep up-to-date with changes in regulatory legislation and guidelines and communicate them to the relevant departments. - **Documentation & Submission**: - Prepare, compile, and submit...

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...

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

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...

Planning and coordinating with project management team, regulatory affairs, analytical development and management team Pivotal involvement in product pre-formulation study and prototype formulation development Preparing reports, compiling/interpreting data and validating stability data of developmental batches Key role involvement in a vast gamut of...