Nutricia Middle East DMCC,a subsidiary of Danone, is looking for Regulatory & Government Affairs Manager United Arab Emirates (AE) DubaiDanone is a global food company holding top positions in healthy food through its four businesses: Fresh Dairy Products, Early Life Nutrition, Waters, and Medical Nutrition. Its mission, bringing health through food to as many people as possible, embodies commitment to human progress and business success. It gives meaning to the work of our 100,000 Danoners worldwide on an everyday basis. For passionate people looking for autonomy and exciting career opportunities, Danone truly has something special inside!
Job title: Regulatory & Government Affairs Manager
Job Family: General Secretary - Regulatory Affairs
Division: Advanced Medical Nutrition
Reporting line: Regulatory & Government Affairs Director
PURPOSE OF THE JOB
Regulatory and government Affairs manager is main contact for all regulatory subjects in Middle East, responsible for all regulatory activates related, including on time submissions, follow up for all registration steps, one time approvals, management of new registrations and products licenses maintenance activities, knows and understands the basics of how the local regulatory role impacts and is impacted by regional Regulatory Affairs Organization.
- To implement the overall regulatory plan for each country.
- Execute Regulatory strategy per each country
- Build a strong stockholder mapping strategy
- To secure registration approvals for new products and secure the regulatory status of the current approved products.
- To solve the regulatory challenges and understand the complex regulatory environment.
Key Performance Indicators
- Understand the regulatory environment in Middle East & be aware of current local regulations and DRA structure and potential changes that will impact the business.
- Active role in interpretation of queries and letters of deficiency raised by authorities
- Establish relationships with regulatory officials to achieve positive outcomes on product approval. Successfully negotiate product specific issues and regulatory challenges.
- Obtain the various regulatory items needed for local submission &perform quality review all regulatory documents to be submitted.
- Follow up with the distributor to ensure that they have received the required registration documents & samples on time.
- Monitoring regulatory expenditure and debit notes received from local distributor related to the local regulatory fees and providing allocation guides to the Finance Department.
- Clear & effective communications with the Regulatory director concerning all the regulatory activates in Middle East
- Submit a regulatory sheet with all activity updates in a monthly basis.
- Create and Review any new created Arabic / English label.
- Execution of activities such as product notifications , registration , certification of products and archiving for all approval certificates
- Coordinate with business leads, Marketing and Supply chain to define strategy, approach and provide technical expertise that support Company products over competition.
- Scan the external environment and do lobbying activities e.g. liaising with other local market-based colleagues (e.g Industry group) to facilitate the review and approval of regulatory submissions.
1. 100 % implementation of the regulatory plan for Middle East
2. On time submission and approval for new products in Middle East as scheduled in the plan.
3. Regular visit to the different ministries of health
4. On time submission of the regulatory activity sheet.
5. Clear & effective communications internally and externally.
6. Able to build effective working relationships and deliver results in wide range of environments and cultures.
Main internal relations:
General Secretary ,Country Manager, Sales Manager, Senior Brand Manager, Finance, Danone medical operations department…
Main external relations:
Distributor, regulatory government authorities
• Attention to details & accuracy.
• Time management, ability to manage several projects in parallel.
• Negotiation skills
• Creativity and Problem solving
• Communications skills
• Product law and regulations
EDUCATION / EXPERIENCE
Education: Bachelors degree
Language Skills: English and Arabic is a must
Relevant Work Experience:
- At least 2 years of experience in a similar position in a renowned Pharmaceutical Company is a must. Experience in Nutrition is a plus
- Gulf Experience is required and Saudi experience is preferred
- Candidate should be familiar with food legislation in different ME countries (Gulf and Levant specifically)
- Successful candidate must be based in Dubai
This position would require travel within the region for about 50% of the time.
For more information about Danone, its people and its business, please visit danone.com We have something special inside, do you?
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