Onsite - Venice, FL / Regulatory Affairs Director / Monday - Friday
Company Overview:
Enzymedica, a global leader in the enzyme supplement industry, is seeking a detail-oriented and knowledgeable Regulatory Affairs Director specifically with SQF and FDA experience for an onsite opportunity in Venice, FL. This role is essential in ensuring that our products meet all regulatory requirements, maintaining our commitment to quality and safety. This person may also have responsibility for Q&A and our state-of-the-art lab. Local candidates or those interested in relocating to the beautiful Venice, FL area are encouraged to apply. This is a critical role for Enzymedica, and this position is required to be onsite with no exceptions.
Resume Details / Qualifications:
- 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”.
Key Responsibilities:
- 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.
Why Join Us?
At Enzymedica, we make great health easier for everyone. It starts with healthy digestion – but that is only the beginning. We have helped digest millions of meals, and our results speak for themselves. Our flagship product, Digest Gold, has been the #1 enzyme product for more than a decade.
We find the best ingredients on the planet, validate them with the latest science then formulate clean, effective products made without compromise. Along the way, we try to make a difference in the world by investing in people and planet initiatives that support our company values and our legacy.
Enzymes are the spark of life — nothing in the body happens without them. We see our team members the same way. From sales and customer success to the warehouse and lab, our hard-working employees help change people’s lives.
Join one of the best companies on Florida’s Gulf Coast. We are hardworking, driven on a mission to change the world, and we proudly offer competitive compensation and comprehensive benefits that reflect our gratitude for our employees. Build a career you will be proud of, at the #1 natural digestive health and wellness company.
We offer great compensation including a full benefit package and a 401K plan with no vesting!
Application Instructions:
If you are local to Venice, FL, or are ready to move to this beautiful city, and meet the qualifications above, we encourage you to apply.
Equal Opportunity Employer
Job Type: Full-time
Application Question(s):
- This position is onsite in Venice, FL. No exceptions at this time. What city do you live in or will you be moving from?
- What is the best email address to contact you at? My email is [email protected]
- US citizen or green card status required for this position. Will you now or in the future require sponsorship for employment Visa status (e.g. H-1B visa status)?
Experience:
- FDA regulations: 10 years (Required)
- SQF: 10 years (Required)
- Regulatory reporting: 10 years (Required)
Work Location: In person
