Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data. Be fully competent to perform all steps within the case-handling processing.
Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector.