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 Requirements 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 Core Competencies 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. Highest-signal resume keywords Regulatory Affairs Experience Regulatory Strategy Development Cross-Functional Team Collaboration Project Management Regulatory Compliance Hard Skills 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 Soft Skills Excellent Communication Skills Analytical Abilities Organizational Skills Influencing Skills Relationship Management Industry Keywords Food Science Regulatory Science Pharmaceutical Sciences Toxicology Biochemistry Nutrition Market Expansion Commercialization Opportunities Stakeholder Engagement Acquisition Integration #J-18808-Ljbffr Jobtailor