Titan Laboratories Hiring For Regulatory Affairs position. Intrested Candidates may send their updated CVs to given email address below.
Department: Regulatory Affairs API
Open Position: 01
Experience Required: 15 To 19 Years
Qualification: BSc/MSc
Location: Navi Mumbai ( Turbhe)
Contact Person – Ms. Shweta Mohite Email: [email protected]
- Responsible for submissions and Lifecycle Management – Europe/UK/US/Canada/WHO and ROW market.
- Making ready the Nitrosamine Risk Assessment Report for Spartan and other drugs.
- Submissions from the USDMF, EU-ASMF, CEP, WHO, and Health Canada are inquiries about responses to the respective regulatory bodies through electronic submissions. (ESG, CESP submissions)
- Submission of US-Amendments/ASMF Updates/CEP Enough revisions depending on suggested adjustments for the drug substances.
- Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.
- Getting and assembling DMF/Technical Packages & Dossiers ready for submission to the Regulatory Agencies of the several nations (US, Europe, WHO, Canada & ROW).
- Experience and knowledge in preparation and review of modules one through three CMC documentation. compiling eCTD sequences in Pharma ready state.
- Validation reports, stability studies, specifications and method of analysis, batch manufacturing records (BMRs/MFRs), and pharmaceutical development reports (PDR).
- Interact with various departments/teams for regulatory documents and compilation on time as per regulatory requirements.
- Maintenance of the whole history of any drug substance (file history with clients or agencies, deficiency responses, corrections, 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.
Audits faced: WHO-GENEVA, USFDA, EDQM, customer audits.
Related Job: Bharat Parenterals Walk-In Interviews for For Store/ Production/ QA
