Regulatory Manager

• Serve as a trusted regulatory advisor to business partners and cross-functional teams on market access, product positioning, regulatory risk, and commercialization opportunities
• Provide regulatory insight to support strategic planning, portfolio management, and business development initiatives
• Assess emerging regulatory developments and advise stakeholders on potential business impacts, opportunities, and risks
• Support integration activities associated with acquisitions, partnerships, and other strategic initiatives
• Partner with R&D and commercial teams to establish regulatory pathways for new products, ingredients, technologies, and claims
• Provide regulatory guidance throughout product development and commercialization activities
• Contribute regulatory expertise to innovation pipeline reviews and stage-gate processes
• Evaluate regulatory requirements and market access pathways for new geographic markets
• Help develop regulatory strategies for global product registrations, authorizations, and commercialization activities
• Monitor U.S. and global regulatory environments and recommend actions to support continued market access and growth
• Oversee regulatory submissions, registrations, and authorization activities
• Review product claims, labeling, technical documentation, and marketing materials for regulatory compliance
• Support development and improvement of regulatory processes, systems, and best practices
• Manage relationships with external regulatory consultants and service providers
• Build partnerships with internal stakeholders across multiple business functions
• Serve as a subject matter expert for complex regulatory matters affecting assigned businesses and product portfolios

• Master's degree or Ph.D. in Food Science, Chemistry, Toxicology, Regulatory Science, Nutrition, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• 8-10+ years of progressive regulatory affairs experience
• Demonstrated success supporting product commercialization, innovation initiatives, and global market expansion
• Experience developing regulatory strategies for new products, ingredients, technologies, or claims
• Experience working effectively with cross-functional teams and senior stakeholders
• Experience managing complex regulatory projects and working with external consultants or regulatory agencies
• Deep understanding of regulatory frameworks relevant to Balchem's products and markets
• Strong business acumen and ability to align regulatory strategies with commercial objectives
• Ability to interpret complex regulatory requirements and translate them into practical business recommendations
• Excellent written, verbal, and presentation skills
• Strong project management, organizational, and analytical abilities
• Ability to influence stakeholders and build effective working relationships across functions and geographies
• Demonstrated ability to manage multiple priorities in a dynamic business environment

Expertise in regulatory affairs with a focus on product commercialization, market access strategies, and compliance across global markets. Proven ability to collaborate with cross-functional teams and influence stakeholders to align regulatory strategies with business objectives.

• Regulatory Affairs Experience
• Regulatory Strategy Development
• Cross-Functional Team Collaboration
• Project Management
• Regulatory Compliance

• Regulatory Strategy
• Product Commercialization
• Regulatory Submissions
• Market Access Pathways
• Regulatory Frameworks
• Technical Documentation Review
• Global Product Registrations
• Regulatory Risk Assessment
• Innovation Pipeline Review
• Regulatory Guidance

• Excellent Communication Skills
• Analytical Abilities
• Organizational Skills
• Influencing Skills
• Relationship Management

• Food Science
• Regulatory Science
• Pharmaceutical Sciences
• Toxicology
• Biochemistry
• Nutrition
• Market Expansion
• Commercialization Opportunities
• Stakeholder Engagement
• Acquisition Integration