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

shweta.m@titanpharma.com


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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