Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.
Dossier & document preparation as per CTD, ACTD & country specific guidelines, Review of dossiers, DMF & Technical documents, Answer query raised from regulatory authority.
Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector.
Drive report timelines and escalate risks or delays to team leads or management. Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template.