Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for 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
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.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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