Encube are looking for best talent for the position of Executive in Regulatory affairs.
Roles and Responsibilities:
1.Dossier compilation of NDA, ANDAs for US market. 2. Exposure to EU will be added advantage.
3. Preferred experience in handling of complex submission, Topical product for e.g. drug device
4.In-depth review of technical and regulatory documents i.e. specification, batch records, method validation documents, stability data, container closure system, DMF review.
5. Hands-on electronic operation (eCTD).
6. Labelling related activities. 7. Behavioral aspects.
Educational Qualification: M. Pharm
Experience – 4-6 Years Location – Marol, Andheri(E), Mumbai.