Regulatory Manager

Balchem; Montvale (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Balchem Corporation seeks a Regulatory Manager to serve as a strategic regulatory partner enabling global product development and market access. This role collaborates across R&D, Marketing, Quality, Legal and Supply Chain to translate complex regulations into practical business solutions.

The Regulatory Manager leads regulatory submissions, ensures compliance, and drives portfolio expansion to support Balchem’s growth and innovation initiatives.

Qualifications

• Master's or PhD in a life science field.
• 8–10+ years of progressive regulatory affairs experience.
• Proven success supporting product commercialization and global expansion.
• Experience coordinating with cross-functional teams and external consultants.
• Deep understanding of regulatory frameworks relevant to Balchem.
• Strong business acumen and ability to align regulatory with commercial goals.
• Excellent written and verbal communication and presentation skills.
• Strong project management and analytical abilities.

Responsibilities

• Serve as regulatory advisor on market access and commercialization opportunities.
• Provide regulatory insights for strategic planning and portfolio management.
• Support global market expansion with regulatory strategies.
• Oversee regulatory submissions, registrations, and authorizations.
• Review claims, labeling, and marketing materials for compliance.
• Collaborate with R&D, Marketing, QC, Supply Chain, Legal on regulatory matters.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Project management

Communication skills

Stakeholder influence

Education

Master's degree in Food Science

PhD in Regulatory Science

Job description

Balchem Corporation, and its subsidiaries, offers a competitive salary and benefits package and is an Equal Opportunity Employer.

Balchem is committed to making the world a healthier place by delivering trusted, innovative, and science-based solutions for the health and nutritional needs of the world. Balchem employs approximately 1,400 employees worldwide who provide the service, quality, and technology that enables our customers to win with their customers. We have built a reputation for delivering results to all of our stakeholders. Founded in 1967, Balchem, a Maryland corporation, became a publicly-traded company in 1970 and is listed on Nasdaq under the symbol “BCPC.” Our corporate headquarters is located in Montvale, New Jersey, and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the U.S. and Europe. The Company consists of three business segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.

POSITION SUMMARY:

The Manager, Regulatory role serves as a strategic regulatory partner supporting Balchem’s businesses. This role is responsible for providing regulatory guidance and support that 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, this individual translates complex regulatory requirements into practical business solutions that support product development, commercialization, portfolio expansion, and global market expansion.

ESSENTIAL FUNCTIONS:

Strategic Regulatory Partnership

• 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.

Innovation and Commercialization Support

• Partner with R&D and commercial teams to establish effective regulatory pathways for new products, ingredients, technologies, and claims.
• Provide strategic regulatory guidance throughout product development and commercialization activities.
• Identify opportunities to leverage regulatory frameworks to support competitive differentiation and market access.
• Contribute regulatory expertise to the innovation pipeline reviews and stage-gate processes.
• Advise cross-functional teams on regulatory implications of emerging technologies, product concepts, and business opportunities.

Global Market Expansion

• Evaluate regulatory requirements and market access pathways for new geographic markets.
• Help develop regulatory strategies to support global product registrations, authorizations, and commercialization activities.
• Collaborate with cross-functional teams, regulatory consultants, trade associations, and external stakeholders to support business objectives.
• Monitor changes in U.S. and global regulatory environments and recommend actions to support continued market access and growth.

Regulatory Compliance and Operational Excellence

• Provide expert guidance regarding regulatory requirements applicable to Balchem products and technologies.
• Oversee regulatory submissions, registrations, and authorization activities, ensuring alignment with business priorities.
• Review product claims, labeling, technical documentation, and marketing materials for regulatory compliance.
• Support the development and continuous improvement of regulatory processes, systems, and best practices.
• Maintain awareness of U.S. and global regulatory developments and communicate relevant business implications to stakeholders.
• Manage relationships with external regulatory consultants and service providers as needed.

Collaboration and Technical Expertise

• Build strong partnerships with internal stakeholders across multiple business functions.
• Influence decision-making through clear communication of regulatory requirements, risks, and opportunities.
• Share regulatory knowledge and best practices with colleagues and project teams.
• 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.