Titan Laboratories Hiring For Regulatory Affairs
DEPARTMENT: REGULATORY AFFAIRS API
NO OF OPEN POSITIONS-1
EXPERIENCE - 15 TO 19 YEARS
Qualification: BSc/MSc
Location: Navi Mumbai ( Turbhe)
Contact Person - Ms. Shweta Mohite
Expected Responsibilities:
Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO and ROW market.
Preparing Nitrosamine Risk Assessment Report for Spartans and other drug substances.
Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to the respective regulatory authorities through electronic submissions. (ESG, CESP submissions)
Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on changes proposed for the drug Substances.
Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.
6. Preparing and compiling DMF/Technical Packages & Dossiers for submission to the Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW).
Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC Documentation. Compiling eCTD sequences through Pharma ready.
Review of Validation reports, Stability studies, Specifications/Method of Analysis, Batch Manufacturing Records (BMR's/MFR's), Pharmaceutical Development Reports (PDR).
Interact with various departments/teams for regulatory documents and compilation on time as per regulatory requirements.
Maintenance of the complete history of each drug substance (Filing history with agencies/ customers, deficiency responses, amendments, annual reports)
Issue Letter of Access and other relevant regulatory documents and their submission to regulatory authorities.
Review of all documents from QA, R&D, AR&D, Production and other department with respect to correctness and compliance for regulatory submission.
Audit Faced: WHO-GENEVA, USFDA, EDQM and Customer audits.
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