Director, Regulatory Affairs

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.
We're 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, and check out some recent press on ByHeart:

• White House Roundtable: President Biden Meets with Infant Formula Manufacturers
• Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula
• Governor Wolf Press Conference: Gov. Wolf highlights state investment in ByHeart, first new formula manufacturer in 15 years
• CBS News: As parents scramble to find baby formula, a new manufacturer is seeing soaring demand
• Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years.

*based on data from infants at approximately 4 months of age
Role Description
Reports To: Chief Medical Officer
Location: New York City, HQ
Start Date: ASAP
The Director, Regulatory Affairs will have responsibility for all regulatory-related innovation and operations/compliance activities for the US and be critical in supporting international expansion strategy and initial execution.
Role Responsibilities

• Interprets and applies FDA regulations/guidance in innovation, product development, and operational/compliance activities
• Develops and leads regulatory strategy to enable US market introduction of novel ingredients/products
• Provides guidance on compliance standards for product composition, manufacturing, packaging, labels/labeling, pre-clinical/clinical studies, pre-market submissions, etc.
• Proactively identifies and internally communicates existing or evolving regulatory risks, and takes action to address them
• Participates in medical, legal, and regulatory reviews of education and marketing content and product and health claims
• Leads interactions with FDA for both innovation and compliance
• Provides thought leadership and recommends a plan of action on regulatory and company initiatives
• Interacts with external partners to determine regulatory strategy for novel ingredients or impact of regulations on ingredients and products
• Engages externally on regulatory policy issues to reflect/embed company interests and shape the outcome
• Ensures regulatory compliance with US, global, and local regulations
• Identifies, develops, and directs projects, programs, and/or processes, inclusive of SOPs, to leverage regulations for the benefit of the company
• Interprets and supports application of GMP and quality-related regulations for QA/QC
• Creates and implements education of regulations to key partners at corporate and facilities
• Champions a culture of collaboration within the organization
• Manages, mentors, and develops a team of regulatory professionals, ensuring achievement of innovation and operational/compliance responsibilities
• Supports development and oversight of departmental budget

Skills & Qualifications

• Master's degree or equivalent in a medical-related field or life science
• 10+ years of relevant experience in Regulatory Affairs in the Pharmaceutical or Food Industry, preferably within the infant/toddler category
• 5+ years of people management experience
• Advanced knowledge of US FDA regulations and product development processes
• Proven ability to develop and drive regulatory strategy
• Effective communicator and business partner
• Ability to lead regulatory initiatives and influence change both internally and externally
• Strong interpersonal, organizational, and leadership skills
• Proactive and goal/detail oriented
• Demonstrated initiative and creativity
• Self-motivated and passion for medical innovation, accurate communication of science, and commitment to scientific rigor

The minimum annual salary for this position is $155,000 and the maximum is $180,000. The salary range for performing this role outside of New York City will differ. Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company's equity program, plus our robust medical, dental, vision, retirement, and other benefits.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.