Regulatory Manager

Balchem Corporation•Montvale, NJ

About The Position

The Regulatory Manager serves as a strategic regulatory partner supporting Balchem’s businesses. The role provides regulatory guidance to enable business growth, accelerate innovation, facilitate entry into new markets, and strengthen competitive positioning. Working closely with R&D, Marketing, Quality, Supply Chain, Legal, and other functions, the manager translates complex regulatory requirements into practical business solutions supporting product development, commercialization, portfolio expansion, and global market expansion. The position advises business partners and cross-functional teams on market access, product positioning, regulatory risk, and commercialization opportunities. It provides regulatory insight for strategic planning, portfolio management, business development, acquisitions, and partnerships, and assesses emerging regulatory developments and their potential business impact. The manager partners with R&D and commercial teams to establish regulatory pathways for new products, ingredients, technologies, and claims; supports product development and commercialization; and contributes regulatory expertise to innovation pipeline reviews and stage-gate processes. The role evaluates requirements and market access pathways for new geographic markets, supports global registrations and authorizations, and monitors U.S. and global regulatory environments. The role also provides expert guidance on regulatory requirements, oversees submissions, registrations, and authorizations, and reviews product claims, labeling, technical documentation, and marketing materials for compliance. It supports improvements to regulatory processes and systems, manages external regulatory consultant and service-provider relationships as needed, and shares regulatory expertise across the organization.

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.

Responsibilities

Serve as a regulatory advisor on market access, product positioning, regulatory risk, and commercialization opportunities.
Provide regulatory insight for strategic planning, portfolio management, and business development initiatives.
Assess emerging regulatory developments and advise stakeholders about business impacts, opportunities, and risks.
Support integration activities related to 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.
Identify opportunities to use regulatory frameworks to support competitive differentiation and market access.
Contribute regulatory expertise to innovation pipeline reviews and stage-gate processes.
Advise cross-functional teams on regulatory implications of emerging technologies, product concepts, and business opportunities.
Evaluate regulatory requirements and market access pathways for new geographic markets.
Help develop regulatory strategies for global product registrations, authorizations, and commercialization.
Collaborate with cross-functional teams, regulatory consultants, trade associations, and external stakeholders to support business objectives.
Monitor U.S. and global regulatory changes and recommend actions to sustain market access and growth.
Provide expert guidance on regulatory requirements applicable to Balchem products and technologies.
Oversee regulatory submissions, registrations, and authorization activities in alignment with business priorities.
Review product claims, labeling, technical documentation, and marketing materials for regulatory compliance.
Support development and continuous improvement of regulatory processes, systems, and best practices.
Communicate relevant business implications of regulatory developments to stakeholders.
Manage relationships with external regulatory consultants and service providers as needed.
Build partnerships across business functions and influence decisions by clearly communicating regulatory requirements, risks, and opportunities.
Share regulatory knowledge and best practices with colleagues and project teams.
Serve as a subject matter expert on complex regulatory matters affecting assigned businesses and product portfolios.