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Regulatory Affairs Specialist
2 months ago
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Contract: North Chicago, Illinois, US
Salary: $30.00 Per Hour
Job Code:
End Date:
Job Description:
Key Responsibilities:
- Assist in the preparation of regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Demonstrate proficiency in developing product registration dossiers, submission documents, progress reports, and amendments.
- Collaborate with teams to formulate regulatory submission strategies and adapt them in response to regulatory updates.
- Engage with affiliates to facilitate interactions with regulatory agencies, aiming to expedite the approval process for pending registrations.
- Participate in project planning, maintaining awareness of regulatory submission strategies and risk management.
- Provide guidance to project teams regarding manufacturing modifications, line extensions, technical labeling, and relevant regulations.
- Coordinate with other regulatory functions to ensure seamless project transitions and successful product launches.
- Assist in the review of change controls to assess the level of change and the necessary submission requirements.
- Compile reports and metrics related to submissions and approvals.
- Offer country-specific regulatory guidance.
- Experience with VEEVA systems is advantageous.
- Direct collaboration with Regulatory Affairs functions, including Regulatory Operations, Submissions Execution, Regulatory Project Management, and other stakeholders such as Project Managers, Manufacturing Plants, R&D, and Product Developers.
- Minimum of 2-3 years of relevant experience and a Bachelor's degree in a nutrition or science-related field.
- Solid understanding and practical experience in diverse regulatory environments across multiple countries.
- Familiarity with the registration filing process for new nutrition products is preferred.
- Knowledge of formulation and scientific principles related to nutritional products.
- Ability to make informed decisions and exercise judgment in selecting innovative solutions to resolve issues. Influence stakeholders on technical matters.
- Adaptability to cultural and political diversity.
- Willingness to learn and challenge the status quo.
- Team-oriented with a self-motivated approach.
- Regulatory Affairs Associate
- Regulatory Affairs
- Regulatory Affairs Specialist
- Regulatory Submission
- Pharmaceutical
- Food Science
- Product Registration
- Dossiers
- Nutrition Science
- Biotechnology
- Pharma
- Pharmaceuticals
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