Regulatory Affairs Manager

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.

When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.

We’re…

• The only U.S.-made infant formula to use organic, grass-fed whole milk
• The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
• The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
• We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
• Less spit up
• Softer poops
• Easier digestion
• More efficient weight gain
• Enhanced nutrient absorption
• Longer stretches between nighttime feeds*

With $250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of 275 people that stretches across the country.

Were proud to offer competitive, family-first benefits, including but not limited to:

1. Health insurance for the whole family: medical, dental, vision insurance covered 100%, with 90% coverage for your family.
2. Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
3. 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
4. Up to 6% 401(k) Match to help you plan for your future.
5. Company equity for every employee: because when we succeed, we succeed together!

Visit our site to learn more

ROLE DESCRIPTION

The Regulatory Affairs Manager is responsible for overseeing regulatory compliance for ByHeart’s product portfolio. This position requires a thorough understanding of regulatory guidelines, particularly in the infant formula industry. This role will ensure compliance throughout the product lifecycle and work closely with cross-functional teams to align regulatory requirements with business objectives. Additionally, the Manager will review and assess product claims across marketing, advertising, and promotional materials to ensure accuracy and compliance with regulatory standards. The ideal candidate will have a strong understanding of FDA regulations, a forward-thinking approach to regulatory challenges, and excellent communication and organizational skills to effectively oversee regulatory compliance.

Reports To: Director of Regulatory Affairs

Location: NYC or Remote

Start Date: ASAP

ROLES RESPONSIBILITIES

• Interpret and apply regulatory requirements across product development, operational activities, and product lifecycle management to ensure compliance in domestic and international markets and support business objectives.
• Lead the label development and review process and assess labels, claims, advertising, and promotional materials for regulatory compliance.
• Support international regulatory compliance reviews and assessments to maintain global standards.
• Develop, implement, and update policies, procedures, work instructions and forms related to Regulatory Affairs to ensure consistency and to promote a culture of regulatory compliance.
• Maintain centralized document management system for Regulatory Affairs. Ensure all documents are available and accurate for auditing purposes.
• Support the preparation, review, and organization of regulatory submission documentation to ensure accuracy, completeness, and compliance with regulatory standards.
• Train internal teams on relevant regulations, directives, and standards to ensure organization-wide understanding and adherence.
• Track and stay current with regulatory developments, assessing their impact on business operations and advising relevant teams to ensure timely compliance.
• Act as the regulatory lead in change control reviews for plant processes, procedures, and label modifications to ensure compliance with regulatory requirements and standards.
• Provide regulatory support for audits, inspections, recalls, and other compliance-related activities.
• Interpret and apply GMP and quality-related regulations (e.g., 21 CFR 106 and 107) to support Quality Assurance and Quality Control efforts.

Skills Qualifications

• Bachelor’s degree in a relevant scientific or medical field.
• 5+ years of experience in Regulatory Affairs within the Food, Pharmaceutical, or another regulated industry, with expertise in compliance; experience in the Infant/Toddler category is a plus.
• Strong knowledge of US FDA regulations, compliance requirements, and product development processes; familiarity with international guidelines is beneficial.
• Excellent analytical skills to interpret regulatory information and requirements accurately, ensuring compliance across all products.
• Excellent interpersonal and communication skills to build effective cross-functional relationships, communicate regulatory updates, requirements, and guidance to internal stakeholders, and collaborate to achieve common objectives.
• Strong project management and organizational skills, with the ability to manage multiple projects and deadlines while maintaining attention to detail.
• High attention to detail to ensure accuracy in documentation, data analysis, and regulatory submissions.
• Adaptability and a proactive approach to stay updated on regulatory changes, assess impacts, and guide the organization in adapting to new standards as needed.
• Demonstrates initiative, self-motivation, and results-oriented mindset, with a commitment to achieving regulatory compliance goals and driving continuous improvement.

The minimum annual salary for this position is $120,000 and the maximum is $135,000. The salary range for performing this role outside of New York City will differ. Additionally, you will be eligible to participate in our company’s equity program, plus our robust medical, dental, vision, retirement, and other benefits