To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process
Senior Manager CETA, you will drive Therapeutic Area performance for CDC India by providing strategic trial insights, leading portfolio planning and execution, and ensuring operational excellence across clinical trial activities.
Bachelors degree in medical, Mechanical, Electric Life Science or other healthcare related majors. Set up new process for entering new data - Regulatory Information Management System.
Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products
Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. ICON plc
Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements
Degree or Diploma in Pharmacy from a recognized University or an Institution duly recognized by the Central/ State Government. Health and Family Welfare Department, Shimla
MPharm. with minimum 5 (five) years of professional experience OR BPharm. with minimum 10 (ten) years of professional experience with valid. Assam Pharmacy Council