Regulatory Affairs Senior Specialist

Posted 09 Sep 2019

Cairo - all, Cairo - Egypt

Req Id 197339

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Manage assigned regulatory tasks related to health authority notifications / submissions / registrations regarding new products, changes to products. Ensure regulatory strategy aligns with overall corporate regulatory strategy, goals and objectives. Carry out regulatory review of documents and changes. Carry out impact assessments where required. In this role you will also assemble and maintain files, and other regulatory documentation to ensure current, and changes recorded. Maintain library/database of standards and regulation. Review of updated regulations, Support preparation of and participate in any audits which require regulatory input. Respond to customer (internal & external) regulatory requests or enquiries.

 

 

  • Support in Preparation & submission dossier for post-approval variations (e.g. safety-related label updates, routine CMC changes such as shelf-life extension, change of manufacturing site), license renewal,
  • Act as point of contact to answer any question and activities related to operational / administrative tasks for preparation, submission and archiving of dossiers.
  • Ensure all technical aspects are covered to enable submissions to health authorities within agreed timelines.
  • Interact closely with and provides guidance to local/regional/global RA
  • Develop. maintain and support cleaning of databases for products
  • Maintain and update regulatory files and records as required; ensure appropriate archiving of all relevant documentation in the appropriate systems in line with applicable internal company standards
  • Support process improvements and implementation of best practices especially for archiving and other technical system.
  • Ensure compliance with local regulations and corporate policies and procedures as directed
  • Assist in preparation of regulatory deliverables (e.g. report generation, excel spreadsheets, power-point presentations)
      
    Minimum Qualifications:
     
  • Bachelors’ Degree in pharmaceutical
  • 3+ years of work experience in a Regulatory Affairs environment
  • Preferable experience working in medical device regulations,
  • Preferable experience working with Biological regulations
     
    Preferred Qualifications:
     
  • Familiarity with global regulations (EU), Africa, Middle East
  • Experience managing regulatory mitigation projects
  • Highly cooperative and collaborative
  • Experience dealing with CAPA; NODCAR; NORCB
  • Experience in labeling activities including submission mock up and artwork preparation (for D2)
     

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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