Regulatory Affairs Specialist
2 weeks ago
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Contract Type: Temporary
Location: North Chicago, Illinois, US
Compensation: $30.00 Per Hour
Job Overview:
As a Regulatory Affairs Associate, you will play a crucial role in supporting regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Your expertise will be vital in the development of product registration dossiers, submission tracking, and managing regulatory amendments.
Key Responsibilities:
- Assist in the preparation and submission of regulatory documents for product registrations across multiple regions.
- Collaborate with teams to devise regulatory submission strategies and adapt them in response to evolving regulations.
- Engage with affiliates to facilitate interactions with regulatory agencies, ensuring timely approvals.
- Participate in project planning and risk management related to regulatory submissions.
- Provide guidance to project teams regarding manufacturing modifications, product extensions, and compliance with relevant regulations.
- Work closely with other regulatory functions to ensure seamless project transitions and product launches.
- Review change controls to assess the impact on regulatory submissions.
- Compile reports and metrics related to submission processes and approval timelines.
- Offer regulatory support tailored to specific countries.
- Experience with VEEVA systems is advantageous.
- Direct collaboration with Regulatory Affairs functions, including Regulatory Operations, Submissions Execution, and Regulatory Project Management, as well as interaction with Project Managers, Manufacturing Plants, R&D, and Product Development teams.
- A minimum of 2-3 years of relevant experience and a Bachelor's degree in a nutrition or science-related discipline.
- Strong understanding of regulatory environments across different countries.
- Experience in the registration process for new nutrition 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 environments.
- Proactive in learning and challenging existing processes.
- Team-oriented with a self-motivated approach.
- Recruiter: Chitrank Rastogi
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