What are the responsibilities and job description for the Senior Regulatory Affairs Manager position at Scientific Search?
Onsite in Laurel, Florida area
Company Overview
A global leader in the enzyme supplement industry.
What You Will Be Doing
Company Overview
A global leader in the enzyme supplement industry.
What You Will Be Doing
- Ensuring that our products meet all regulatory requirements
- Perform, manage and oversee Regulatory Compliance: Ensure that all documents and processes comply with FDA regulations, particularly CFR 21 Parts 111 and 117 as well as SQF.
- Documentation Management: Generate and maintain regulatory documents, ensuring accuracy and compliance with relevant standards.
- Label Review and Supplement fact panel generation: Generate supplement fact panel, evaluate, and approve labels for new products, ensuring they meet all regulatory and compliance requirements.
- International Registration: Manage the international registration of products, ensuring compliance with global regulations.
- Submit and manage all certifications, including non-GMO, Kosher, clean label, etc.
- Adaptability: Stay up to date with regulatory changes, adapting processes and documentation to remain compliant.
- Day-to-Day Operations: Engage in a variety of tasks daily, providing support across multiple projects and ensuring all documentation is up-to-date and compliant.
- Proven experience in regulatory compliance, particularly in the supplement or pharmaceutical industries.
- Strong understanding and experience working with these specific FDA regulations (CFR 21 Parts 111 and 117) as well as SQF.
- Current industry knowledge and keen awareness of ongoing changes in regulatory standards and the ability to adapt to these changes swiftly.
- International experience – we service multiple countries.
- FDA audit experience.
- Know and understand “best practices” for managing a dietary supplement.
- Experience with “Structure Function Claims”.
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