Mar 08, 2018

DRA Manager UAE & Yemen Job Placement - Novartis

  • Novartis International AG
  • Dubai - United Arab Emirates
Full time Health Care Jobs Science, Research & Development Jobs

Job Description

Job Title:  DRA Manager UAE & Yemen

Company Name: Novartis

Location: Dubai, United Arab Emirates (UAE)

 

Key Duties and Responsibilities:

  • Active coordination of the preparation and submission of the registration files in a timely manner, in line with the registration planning and ME management instruction
  • Review and compile the M1 in cooperation with the RCC department and the local distributors to fulfil the local requirements and ensure smooth and rapid submission of the files.
  • Prepare, review and release the artworks in coordination with the countries and the manufacturing site
  • Review and Validation of the promotional material and regulatory support for the compliance committee.
  • Co-ordinate and respond to requests by the authorities during the evaluation process, and check the correct handling of deficiency letters within a specific timeframe ( 15 to 45 days Max)
  • Follow up the maintenance of the registered products (Renewal/variation) in coordination with the LCM (Life cycle maintenance) department and the supply chain department in order to ensure smooth supply and stock management.
  • The incumbent will also complete and regular archiving the registration files and related documents
  • Close follow up and monitoring of the regulatory activity with the local distributors ( Bi-weekly / or monthly meeting)
  • Monthly reporting of the activity ,regular and accurate updating of the tracking tools
  • Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued from the MoH, and immediate implementation within the company
  • Improve and encourage the compliance practices related to the DRA activity and Sandoz business
  • Regulatory Support for the local business development activity: Local packaging/ licensing/local manufacturing) Regulatory support for the tender business

 

Qualifications, Skills and Experience: 

  • The applicant must hold a University Degree in Science English and Arabic
  • Two to three years experience in the regulatory field ( new submission/ maintenance activity/ tender/ pricing) in the Gulf countries.

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