Accountability / Scope:

• As the 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 global.

• Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.

• Individual shall be good with excel and numbers, so that they can help analyze submission numbers & various metrics.

RESPONSIBILITIES

Major Responsibilities:

• Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc
• Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes
• Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
• Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
• Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
• Partner with other regulatory functions for smooth project transition and launch.
• Support review of change controls to determine the level of change and consequent submission requirements
• Support pulling reports, metrics related to submissions and approvals.
• Offers country specific regulatory support
• System VEEVA experience is helpful

Stakeholders:

• Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers.

Skills/Experience Requirements

Requirements include:

• Prior experience (2-3yrs) and Bachelor s degree in nutrition/science related field.
• Good understanding and working experience in different regulatory environment in multiple countries.
• Experience in registration filing process of new nutrition products preferred.
• Knowledge and understanding of formulation & scientific aspects of nutritional products.
• Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
• Adaptable in cultural and political diversity.
• Capacity to learn and challenge status quo.
• Team player
• Self-motivated.