Regulatory Affairs Specialist-Entry Level

As a professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP globally. The individual will develop partnerships with other regulatory functions, affiliates, and stakeholders to define plans and strategies for submissions, address deficiencies, and develop approaches to solutions. Proficiency in Excel and numerical analysis is essential for analyzing submission numbers and various metrics.

Major Responsibilities:

• Regulatory Submissions: Support regulatory submissions for Food for Special Medical Purposes (FSMP), Enteral Nutrition, Infant Formula (IF), Follow-Up Formula (FUF), and Drug products for EURI/MENAP/global regions. Develop skills in supporting the development of product registration dossiers, submission progress reports, addressing deficiencies, and amendments.
• Strategy Development: Assist teams in developing regulatory submissions strategies and update strategies based on regulatory changes.
• Agency Interactions: Partner with affiliates to support regulatory agency interactions to expedite the approval of pending registrations.
• Project Plans: Participate in project plans and regulatory submission strategies, including risk management. Advise project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
• Project Transition: Collaborate with other regulatory functions to ensure smooth project transitions and launches.
• Change Controls: Support the review of change controls to determine the level of change and consequent submission requirements.
• Reporting: Pull and analyze reports and metrics related to submissions and approvals.
• Country-Specific Support: Provide country-specific regulatory support.
• System Experience: Experience with VEEVA systems is helpful.

Stakeholders

Direct interaction with Regulatory Affairs functions including:

• Regulatory Operations
• Submissions Execution
• Regulatory Project Management
• Strategic Area
• Project Managers
• Manufacturing Plants
• Affiliates
• R&D Technical Center
• Product Developers

Skills/Experience Requirements

• Education: Bachelor’s degree in nutrition/science-related field.
• Experience: 2-3 years of prior experience in regulatory affairs.
• Regulatory Environment: Good understanding and working experience in different regulatory environments across multiple countries.
• Registration Filing: Experience in the registration filing process of new nutrition products is preferred.
• Product Knowledge: Knowledge and understanding of formulation and scientific aspects of nutritional products.
• Decision Making: Exercises judgment in selecting innovative and practical methods to achieve problem resolution. Influences stakeholders on technical solutions.
• Cultural Adaptability: Adaptable in cultural and political diversity.
• Learning Capacity: Capacity to learn and challenge the status quo.
• Team Player: Strong team player.
• Motivation: Self-motivated.