Encube Ethicals pvt ltd
Encube Ethicals are hiring for Regulatory Affairs Department.
Department: Regulatory Affairs.
Qualification: M Pharmacy / MSc
Experience: 3-9 Years.
Location: Andheri (Marol), Mumbai.
- Experience and exposure to Semi-Regulated Market, Experience in complex dosage form
- Understanding labelling related activities, Knowledge in reviewing of CMS/Clinical/Regulatory
- documentation required for submission.
- Dossier compilations of NDA, ANDAS.
- Experience in handling of complex submission (topical products).
- In-depth review of technical and regulatory documents, i.e. specifications, batch records, method validations documents, stability data, container closure system, DMF review.
- Hands on electronic operations (eCTD and SPL).
- Labelling related activities.
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