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.
Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry.
Support EU Generics Labeling Managers and Labeling Germany Managers in providing pharmaceutically and medically accurate product labelling, especially for multiple regulatory procedures of one INN.
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.