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Akums Drugs & Pharma

 

Akums Drugs & Pharma Hiring B.pharma,M.pharma for Officer- DRA

Akums Drugs & Pharmaceuticals Ltd Recruitment 2021.Akums Drugs & Pharmaceuticals Ltd Notification full detailes below.Akums Drugs & Pharmaceuticals Ltd., is largest contract manufacturing company engaged in manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals and more.

Important Vacancy details:

  1. Post Name: Officer- DRA
  2. Education:B.pharma,M.pharma
  3. Experience:2 – 4 years
  4. Location:Delhi
  5. Salary: NA
  6. Openings: 01
  7. Address;AKUMS DRUGS & PHARMACEUTICALS LTD., 301-305, MOHAN PLACE, L.S.C, BLOCK-C SARASWATI, VIHAR, DELHI-34, NEW DELHI, Delhi, India. 
  8. Contact: Ms. Nikita Sehgal, Contact No.:- 8800461116

: Hiring For Officer- DRA in Akums Drugs & Pharmaceuticals Ltd! 

  • Regulatory filing strategy evaluation for Domestic Market.
  • 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.

Selection Process: The selection will be on the basis of Interview.



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