Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Regulatory Affairs Associate with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at 1 732 355 7412.

Role: Regulatory Affairs Associate

Location: Abbott Park, IL

Duration: 8 Months contract only

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.