Akums Drugs & Pharmaceuticals Ltd is hiring for Officer- DRA.Akums Drugs & Pharmaceuticals Ltd., is largest contract manufacturing company engaged in manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals and more.
Vacancy Details :
- Company Name: Akums Drugs & Pharmaceuticals Ltd
- Location : Delhi
- Post Name: Officer- DRA
- Qualification: B.pharma,M.pharma
- Experience: 2 – 4 years
- No of Vacancies: 01
- Details of Salary: Details not provide by recruiter
- Contact: Ms. Nikita Sehgal, Contact No.:- 8800461116
- Mode of application : Online
- Selection Process: Personal interview
- Address;AKUMS DRUGS & PHARMACEUTICALS LTD., 301-305, MOHAN PLACE, L.S.C, BLOCK-C SARASWATI, VIHAR, DELHI-34, NEW DELHI, Delhi, India.
Job Description/Skills Required :
- Author high-quality CMC documentation for domestic submission, with support and guidance, applying agreed CMC domestic regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines throughout project lifecycle.
- Preparing CMC responses to health authority questions during development, registration and product lifecycle.
- Identification of required documentation for domestic submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identification of content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep updates with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Preparation of various application Documents (Covering letter, Various application, medical rationale, executive summary for SEC referral For filing of FDC applications.
- Preparation of Import License Application.