<ul><li>Preparation of DMF/ASMFs and their registration processes in the regulatory regions [US, Canada, Europe, Japan etc] as well as ROW.</li><li>Preparation of Applicants Parts, Tech Pack, life cycle management [updates, amendments, CEP revision &amp; variations]</li><li>Drafting of response to Agency’s deficiencies and customer DMF review comments for all global regions.</li><li>Sound knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.</li><li>Good scientific conceptual knowledge to review and evaluate the R&amp;D, AR&amp;D, QA, QC documents (Change controls, stability report, analytical validation report etc) at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.</li><li>Must acquainted with eCTD software. Should have hands on experience on eCTD regulatory submission tools.</li><li>Should have a sound knowledge on the all requirements to respond to the deficiencies.</li></ul>

Associate - Regulatory Affairs