Dossier & document preparation as per CTD, ACTD & country specific guidelines, Review of dossiers, DMF & Technical documents, Answer query raised from regulatory authority.
Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry.
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.
Perform various microbiological tests such as water analysis, MLT, BET, handling of Bio ball cultures. Analysis of finished products, raw materials, and components