To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & 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:

• 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.