Regulatory Affairs Manager
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Job Location:
Florida City, FL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About Fullscript
Were an industry-leading health technology company on a mission to help people get better. We started in 2011 with one simple idea. Make it easier for practitioners to access the products they trust so they can deliver better care.
That simple idea grew into a platform that powers every part of care. Today more than 125000 practitioners use Fullscript for clinical insights lab interpretations patient analytics education and access to high-quality supplements. Over 10 million patients rely on Fullscript to stay connected to their care plans and follow through on treatment.
We build tools that make care smarter and more human. Tools that save time simplify decisions and help practitioners stay closely connected to the people they care for. When everything they need is in one place they can focus on what matters most: helping people get better.
This is your invitation.
Bring your ideas your grit and your care for people.
Join us and shape the future of care.
Were looking for a Regulatory Affairs Manager whos passionate about dietary supplement and NHP compliance and ready to help drive end-to-end regulatory operations across North America. Youll be hands-on with FDA 21 CFR Part 111 DSHEA NSF 455-2 and Health Canadas NHP regulations with the ultimate goal of ensuring our products warehouses and documentation consistently meet the highest standards while every process stands up to regulatory scrutiny.
This is a hands-on high-visibility role where youll partner closely with Quality Legal and Distribution teams to keep our systems inspection-ready and our documentation watertight. Youll work across a fast-moving operation with more than 17000 SKUs and five warehouses maintaining our commitment to flawless compliance as we continue to scale..
Its an excellent opportunity for someone who enjoys solving complex compliance challenges leading through influence and is eager to grow into broader leadership as our team expands.
Join us to build the next chapter of Fullscripts regulatory journey!
What Youll Do:
- Maintain ongoing compliance with FDA 21 CFR 111 DSHEA and NSF 455-2 for finished dietary supplements.
- Manage Health Canada NHP site and product licensing importation compliance and regulatory documentation.
- Review and approve labels claims and substantiation for dietary supplements and NHPs.
- Support audit readiness for FDA NSF and Health Canada inspections including CAPA documentation and process follow-up.
- Oversee facility registrations supplier qualifications and product listings across U.S. and Canadian markets.
- Partner with Quality Legal and Distribution to resolve compliance issues and strengthen product lifecycle controls.
- Monitor regulatory updates and proactively align internal processes to new requirements.
- Contribute to SOP QMS and continuous improvement initiatives that reinforce Fullscripts compliance excellence.
What You Bring:
- 5 years of progressive experience in regulatory affairs or quality compliance within dietary supplements and/or NHPs.
- Working knowledge of FDA dietary supplement regulations (21 CFR 111 DSHEA NSF 455-2) and Health Canada NHP frameworks.
- Experience supporting or preparing for FDA NSF or Health Canada inspections.
- Proven ability to manage labeling claims supplier documentation and GMP records with precision.
- Strong communicator with the confidence to collaborate across teams and influence without authority.
- Bachelors degree in life sciences chemistry or a related field.
Bonus if you have...
- Experience in a multi-site or high-SKU operation (distribution or manufacturing).
- Familiarity with digital QMS or regulatory systems (ZenQMS NetSuite etc.).
- Knowledge of Prop 65 or FTC claim substantiation.
Why Youll Love Fullscript:
- Market competitive compensation package including equity
- 401K matching (within US)//RRSP matching (within CAD)
- Flexible PTO policy
- Flexible benefits package and additional perks
- Employee discount on Fullscript catalog of products for family & friends
- Ability to *Work Wherever You Work Well*
Why Fullscript
Great work happens when people feel supported trusted and inspired. At Fullscript we stay curious and keep finding smarter ways to make care better. We grow together take on new challenges and focus on impact. We put people first work as a team and leave egos at the door.
What to Know Before You Apply
Were grateful for the interest in joining Fullscript. To make sure your application reaches our hiring team please apply directly through our careers page. Were not able to respond to individual messages about open roles on email or social channels.
Fullscript is an equal opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request at emailprotected.
All offers are contingent on successful background checks conducted in compliance with federal state and provincial laws.
We use AI tools to support parts of the hiring process including screening and reviewing responses. Final hiring decisions are always made by people and follow all applicable privacy and employment laws in Canada and the U.S.
Learn More
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Join thousands on Fullscript in making health last with a platform for personalized treatment planning, active wellness support, and top-quality supplements.
