Regulatory Affairs Specialist
2 weeks ago
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- Job Description
Contract Type: Contract
Location: North Chicago, Illinois, US
Compensation: $30.00 Per Hour
Job Overview:
Responsibilities:
- Assist in the preparation and submission of regulatory documents for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Demonstrate proficiency in creating product registration dossiers, submission updates, and managing compliance reports.
- Collaborate with teams to formulate regulatory submission strategies and adjust plans in response to regulatory updates.
- Engage with affiliates to facilitate interactions with regulatory agencies, aiming to accelerate the approval process for pending registrations.
- Participate in project planning, regulatory submission strategies, and risk management discussions.
- Provide guidance to project teams regarding manufacturing modifications, product line extensions, technical labeling, and applicable regulations.
- Coordinate with other regulatory departments to ensure seamless project transitions and successful product launches.
- Assist in the evaluation of change controls to assess the impact and necessary submission requirements.
- Compile reports and metrics related to regulatory submissions and approvals.
- Offer country-specific regulatory insights and support.
- Experience with VEEVA systems is advantageous.
- Direct engagement with Regulatory Affairs functions, including Regulatory Operations, Submissions Execution, Regulatory Project Management, and other relevant stakeholders such as Project Managers, Manufacturing Facilities, R&D teams, and Product Developers.
- A minimum of 2-3 years of relevant experience and a Bachelor's degree in a nutrition or science-related discipline.
- Comprehensive understanding of regulatory environments across multiple countries.
- Experience in the registration process for new nutritional products is preferred.
- Knowledge of formulation and scientific principles related to nutritional products.
- Ability to make informed decisions and influence stakeholders regarding technical solutions.
- Adaptability to diverse cultural and political contexts.
- Willingness to learn and challenge existing practices.
- Strong team collaboration skills.
- Self-driven and motivated individual.
- Recruiter: Chitrank Rastogi
Interested candidates are encouraged to apply through the appropriate channels.
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