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Regulatory Manager/Head

Job ID: 340923000022087031  |  Industry: Pharma  |  Posted Date: 28-04-2020

We are looking to hire a Regulatory Manager/Head for our client which is a leading business conglomerate with diversified business across middles east, India and Africa in different verticals including retail, FMCG, Manufacturing, hospitality, Construction, and healthcare.

 

For their healthcare/Pharmaceutical division they are looking to hire a Regulatory Manager/Head who will be the senior most person in the Regulatory department and will have the responsibility to manage the department from the scratch which gives the opportunity to a person to grow with the Organisation. We need someone who can work from the scratch initially and gradually develop the department in the coming years.  

 

Following are the job requirements:

 

  • The primary responsibility includes new products submissions, minor variations, post approval reporting obligations and general product life cycle management applicable to UAE and regional countries.
  • 4+ years of solid Regulatory affairs experience in UAE & GCC countries in a medium to large size reputable organization/s for pharmaceutical products.
  • In-depth understanding of regulation in UAE & GCC countries for registration of Innovator pharma product/ Generics pharma products / Herbal products GSL & nutraceuticals / Medical devices / DM approvals for food /cosmetics etc.
  • New Product registration, New Manufacturing Site/ MAH registration & relevant CPP/FSC legalizations experience. Preparation of regulatory dossiers & knowledge of eCTD software’s, eCTD dossier compilations. (Must have submitted a minimum of 2-3 submissions in last 1 year).
  • Re-Registration / Minor variations / appeal of price revision of the product.
  • For assigned products, Patient Package Inserts, local physicians' circulars, packaging material, Artwork, labelling approvals, analytical calculations experience.
  • Knowledge of analytical labs requirements for herbal and GSL products.
  • Knowledge of preparation of all modules in regulatory dossier including bioequivalence / stability / ICH guidelines etc.
  • Knowledge of DCC, HAAD Code & market access documentation.
  • Prepare and update week, monthly project plans, timelines of approvals and planned submissions to management.

 

Educational Qualifications:

  • M Pharma / B Pharm qualification from an accredited institution / university.
  • GGC DRA or similar qualification would be an added advantage.
  • Windows MS Office/ Adobe / USDMF & EQdm / EMA & USFDA Data Mining

 

If you feel you have the capability to handle the role and have the relevant experience and willing to take the challenge with the growing Organisation please apply and we shall get back to you should you meet the requirements.



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