ARMRA
Senior Manager Of Regulatory Affairs (Remote)
Senior Manager Of Regulatory Affairs | ARMRA | UnitedStates
Job Title: Senior Manager of RegulatoryAffairs
Job Type: Full-Time (Remote)
...Senior Manager Of Regulatory Affairs | ARMRA | United States
Job Title: Senior Manager of Regulatory Affairs
Job Type: Full-Time (Remote)
ARMRA Schedule: MUST be able to work Monday-Friday 7AM – 4PM PST)
About ARMRA:
ARMRA is reimagining immune health by developing cutting-edge, natural products powered by colostrum — nature’s 300 million-year-old superfood. Leveraging our proprietary Cold-Chain BioPotent Pasteurization Technology, ARMRA harnesses the immune intelligence of colostrum’s 400+ bioactive nutrients to support complete immune health and cellular performance. We are committed to safety, clean product development, environmental sustainability, and scientific transparency.
This is an exciting opportunity to join a high-growth, science-driven consumer health startup that is revolutionizing a category and redefining health paradigms for the modern era.
The Role:
The Senior Manager of Regulatory Affairs will play a pivotal role in ensuring compliance across all ARMRA product lines, marketing, and operations. This role requires expertise in dietary supplement regulations, collaboration with cross-functional teams, and a proactive approach to navigating complex regulatory landscapes. Reporting to the Director of Science, this position will partner closely with the Marketing, Science, Quality Assurance, and Product Development teams to ensure accuracy and compliance in all communications and product offerings.
Application Instructions:
When applying, please include a cover letter detailing your experience with regulatory compliance in the dietary supplement industry. Highlight a specific project or initiative you led that demonstrates your ability to navigate complex regulations.
Responsibilities:
Regulatory Compliance:
- Stay updated on FTC, FDA, and other relevant dietary supplement regulations.
- Review and approve marketing materials, product labels, and social media content to ensure claims are substantiated, truthful, and compliant.
- Oversee product labeling, including supplement facts panels and allergen declarations, ensuring FDA compliance (21 CFR 101).
Documentation Management:
- Develop and maintain comprehensive regulatory documentation, including SOPs, raw material specifications, and finished product specifications.
- Lead stability testing programs, including protocol design and final documentation review.
Quality Systems:
- Collaborate with the Quality Assurance and Product Development teams to ensure compliance from concept to commercialization.
- Support the creation and maintenance of cGMP-compliant systems (21 CFR 111).
Stakeholder Collaboration:
- Partner with legal, marketing, and scientific teams to address regulatory inquiries and ensure alignment.
- Serve as a subject matter expert, providing guidance on compliance and substantiation for all claims and marketing strategies.
Qualifications & Skills:
- Bachelor’s degree in Chemistry, Biology, or related field (advanced degree preferred).
Experience:
- 3-5 years of experience in regulatory affairs or quality assurance within the dietary supplement or pharmaceutical industry.
- Strong knowledge of FDA regulations (21 CFR 111 and 101) and FTC guidelines.
Skills:
- Exceptional written and verbal communication skills.
- Strong analytical and critical thinking abilities.
- Detail-oriented with a proven ability to manage multiple projects effectively.
Preferred Skills:
- Familiarity with marketing strategies in the dietary supplement industry.
- Experience with Canadian and European regulatory frameworks for dietary supplements is a strong bonus.
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, ancestry, sex, religion, gender, gender identity or expression, sexual orientation, marital status, national origin, genetics, disability, age, veteran status, or other characteristics.
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