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Regulatory Affairs Officer (M/W)

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Reporting to the Legal Counsel Middle-East and India, you will be responsible for the registration and licensing of our products with the regulatory agencies in compliance with the applicable legislation in the Middle-East and India. You will also identify regulatory trends and keep the business regularly updated.

Your main responsibilities are :

Meet the requirements of regulatory agencies through registrations and licenses  :

  • Specify import storage, labelling, licensing, marketing and packaging requirements and ensure that all our products meet these requirements
  • Direct the collection and preparation of samples as requested by regulatory agencies
  • Coordinate with the HQ in Paris and the Office in Dubai the preparation and submission of regulatory documents
  • Review all submission materials to ensure timeliness, accuracy, comprehensiveness and compliance with regulatory standards
  • Develop implementation plans for the preparation and submission of new products in light of regulatory strategies
  • Advise project teams on subjects such as premarket regulatory requirements, import, packaging and labeling requirements
  • Prepare submissions for new product licenses
  • Monitor and set timelines for license variations and renewal approvals

Manage activities such as audits, inspections or product recalls :

  • Coordinate recall of products or market withdrawal activities as necessary
  • Support with internal or external audits
  • Undertake and manage regulatory inspections
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested

Analyze and assess regulatory trends and share knowledge and expertise with the teams :

  • Create, compile and maintain regulatory documentation, databases, standard operating procedures, policies and systems
  • Identify and interpret regulatory rules or rule changes
  • Communicate and recommend amendments to Company corporate policies and procedures
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
  • Monitor regulatory affairs trends that are related to environmental issues

You have a University degree and 5 years of experience in the region with deep knowledge of Middle-East regulations. Pro-active and rigorous, you have a keen eye for details and strong analytical skills. Most of all, you are hands-on and solution oriented. You have excellent interpersonal skills and an agility in your communication.

English and Arabic are a must.
Position based in Dubai

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