Manager-Biologics Regulatory Affairs(Clinical Trials)

3 days ago


Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 15,00,000 - ₹ 25,00,000 per year

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities:

  1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

  2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

  3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

  4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

  5. MOH Query response

  6. Product Life cycle Management

  7. RA support for Plant related QMS activities



  • Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    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...


  • Mumbai, Maharashtra, India USV Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    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,...


  • Mumbai, Maharashtra, India, Maharashtra Ipca Laboratories Limited Full time

    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...


  • Mumbai, Maharashtra, India USV Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    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...


  • Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    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...


  • Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    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,...


  • Mumbai, Maharashtra, India Ipca Laboratories Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    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...


  • Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    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,...


  • Mumbai, Maharashtra, India Syneos Health Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    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...


  • Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    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...