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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