We at Encube Ethicals are hiring for Regulatory Affairs Department.
Department: Regulatory Affairs.
Qualification: M.Pharm-M.Sc.
Experience: 3-6 Years.
Location: Andheri (Marol), Mumbai.
Skills Requirements :
- Experience and exposure to Semi-Regulated Market,
- Experience in complex dosage forms,
- Understanding labeling-related activities,
- Knowledge in reviewing CMS/Clinical/Regulatory documentation required for submission.
Job Description:
1. Dossier compilations of NDA, ANDAs for Semi-regulated markets
2. Experience in handling complex submission (topical products),
3. In-depth review of technical and regulatory documents, i.e. specifications, batch records, method validations documents, stability data, container closure system, and DMF review.
4. Hands-on electronic operations (eCTD and SPL).
5. Labelling-related activities.
6. ETC.
Interested candidates kindly share your updated CV at jeel.c@encubeethicals.com
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