Manager-Biologics Regulatory Affairs(Clinical Trials)

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...

USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.Explore us at Function: BiologicsPosition: Deputy Manager/Manager - Regulatory Affairs (Clinical)Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working,...

Designation : Asst Manager/Manager – Medicoregulatory Affairs Department : Medicoregulatory AffairsJob location : Kandivali-West, MumbaiResponsibilities I To independently review following applications online through Sugam Portal to CDSCO:Import license of reference product for BE studiesBE study NOC for export purpose Manufacture of new drugs to be...

USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.Explore us at Function: BiologicsPosition: Deputy Manager/Manager - Regulatory Affairs-CMCJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd...

Position Title: Sr. Manager/ Manager Clinical Quality Compliance and TrainingYOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical...

Role & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...

Designation: Asst Manager/Manager – Medicoregulatory AffairsDepartment: Medicoregulatory AffairsJob location :Kandivali-West, MumbaiResponsibilitiesI To independently review following applications online through Sugam Portal to CDSCO:Import license of reference product for BE studiesBE study NOC for export purposeManufacture of new drugs to be introduced...

Role & responsibilitiesPreparation and reviewing of CTD and ACTD dossier.Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.Co-ordination with plant for Regulatory compliances.Timely achievement of monthly plan & timely query response.Gap Analysis/Updation of Master data.Review of Change Controls, Stability Protocol,...

Job Responsibilitiesminimum 2 Years of project management experience.Should have global pharma experience.Candidate from Mumbai location preferred.Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executedImplement clinical research protocols and ensure compliance with regulatory...

Job Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...