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Regulatory Submissions Coordinator
2 months ago
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- Job Description
Contract Type: Temporary
Location: North Chicago, Illinois, US
Compensation: $30.00 Per Hour
Job Overview:
We are seeking a dedicated Regulatory Affairs Associate to join our team at Collabera. This role is essential in supporting regulatory submissions across various sectors including Food, FSMP, Enteral Nutrition, and Pharmaceuticals.
Key Responsibilities:
- Assist in the preparation and submission of regulatory documents for product registrations, including 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, ensuring timely approvals for pending registrations.
- Participate in project planning and risk management related to regulatory submissions.
- Provide guidance to project teams regarding manufacturing changes, technical labeling, and compliance with relevant regulations.
- Work closely with other regulatory functions to ensure seamless project transitions and product launches.
- Review change controls to assess submission requirements based on the nature of changes.
- Compile reports and metrics related to submissions and approvals.
- Offer country-specific regulatory support as needed.
- Experience with VEEVA systems is advantageous.
- Directly interact with various Regulatory Affairs functions, including Regulatory Operations and Project Management, as well as other stakeholders such as Project Managers and Product Developers.
- A Bachelor's degree in a nutrition or science-related field with 2-3 years of relevant experience.
- Comprehensive understanding of regulatory environments across multiple countries.
- Experience in the registration process for new nutrition products is preferred.
- Knowledge of formulation and scientific principles related to nutritional products.
- Strong decision-making skills and the ability to influence stakeholders on technical matters.
- Adaptability to diverse cultural and political contexts.
- Willingness to learn and challenge existing practices.
- Ability to work collaboratively in a team setting.
- Self-motivated and proactive in approach.
- Recruiter: Chitrank Rastogi
