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