Regulatory affairs Vacancies – Encube Ethicals – M pharm / Msc

Encube Ethicals are hiring for Regulatory Affairs Department.

Department: Regulatory Affairs.

Qualification: M Pharmacy / MSc

Experience: 3-9 Years.

Location: Andheri (Marol), Mumbai.

Skills Requirements:

• 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.

Job Description:

• 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.
• ETC.

Can share your cv on shraddha.s@encubeethicals.com