Regulatory Affairs Manager (Gulf Based in Cairo)

Danone MENA is looking for a highly dynamic Regulatory Affairs Manager - Gulf & UAE for its Specialized Nutrition Business in the Middle East and North Africa region to be based in Cairo, Egypt.

This role is designed to:

• Play a crucial role in ensuring compliance with regulatory requirements across multiple Gulf countries, and acts as the interface between distributors/customers, manufacturing sources, particularly in relation to our upcoming launches and operational expansions.
• Requires a deep understanding of regional regulatory frameworks and the ability to navigate complex requirements efficiently.
• Monitor registration files (documents request and review, compilation of files, send to submission) and label control.
• Maintain the registration of all the companies’ product up to date and ensure that all products can reach the market without any regulatory constraint.
• Responsible for maintaining an updated and active regulatory folder and Tracker to ensure smooth submissions .

KEY CHALLENGES

• • Business coverage includes UAE, Kuwait, Oman, Qatar, and Bahrain.
  • Ensure maintenance of valid licenses for business operations to uphold regulatory compliance and ensure business continuity.
  • Harmonize product portfolio registration across the region by ensuring timely submissions to Health Authorities.

KEY ACCOUNTABILITIES

• • Maintain the master data file related to labels and registration requirements per country.
  • Validate and organize documentation required for regulatory submissions
  • Maintain proactive communication with distributors to facilitate timely submission of regulatory documents and ensure compliance with local regulations.
  • Manage and update the registration tracker (Excel sheet) including document requests, submission dates, Health Authority (HA) comments, and registration statuses.
  • Manage label approvals to ensure timely updates in the system.

KEY PERFORMANCE INDICATORS

• 100 % implementation of the regulatory plan for Gulf
•  On time submission as scheduled in the plan.
• Clear & effective communications.
• Updated tracker sheet

JOB DIMENSIONS

1. Business impact (Value added of this role and contribution to the business (direct and indirect CANN impact, size of budget and/or headcount to manage):The impact of this job on profit and loss is indirect. However the role is very critical ensuring the license to operate through product and factory registrations will ensure business continuity which will impact the sales revenues.

1. Strategic contribution (CODI or leadership team membership, size and significance of portfolio to be managed, level of responsibility in the strategic planning process of the CBU, number and size of projects, etc.):Accelerate innovation entry to the markets and ensure marketing plans execution.

1. Geographic scope of the job: Gulf (UAE, Kuwait, Oman, Qatar, and Bahrain)

1. Main internal relations (size and function of the internal network and the role of this position in these networks):Dealing with multiple stakeholders (Suppliers, Global team, D2D team, Marketing, sales)

1. Main external relations (size and function of the external network (HCPs, scientists, stakeholders, etc.) and the role of this position in these networks):Different distributors on different countries, agencies

To be successful in the role you should ideally have

Education and professional experience:

• Education: pharmacy, nutrition or dietetics, or equivalent bachelor's degree in life sciences
• 3 to 5 years in a similar role within an FMCG, pharmaceutical or nutrition company. Multinational experience is preferred
• Detail oriented, thorough, excellent follow up
• Candidate will need to be based in Cairo and willing to travel for business needs

Location:

Cairo, Egypt.

Languages required

• Fluent in Arabic, English

Functional Competencies

• Change management
• Systematical approach
• Problem solving
• Analytical
• Proficient in the use of excel and PowerPoint

Soft Skills

• Detail oriented
• Compliance and process driven mindset
• Strong stakeholder management and relationship building abilities
• Strong ethics and values
• Excellent communicator and communication skills
• Open minded, collaborative
• Able to build trust
• Ability to take calculated risks and make prompt and balanced decisions
• Results driven
• Ready to challenge status quo.
• Strong follow up

Mobility

• Ideally the candidate should be open to move within the region or outside the region within Danone in 3-4 years, if such opportunity will arise which and contribute to his/her career growth

Danone Values

Candidates are expected to adhere to Danone’s core values: Humanism, Openness, Proximity & Enthusiasm.