Global Regulatory Strategy Lead

Balchem Corporation; Montvale (NJ); On-site; USD 120,000 - 190,000; Full time

Job summary

Balchem Corporation in Montvale, NJ seeks a Manager, Regulatory to partner with R&D, Marketing and Quality to guide regulatory strategy, enable market access, and support global expansion. You will lead regulatory submissions, monitor developments, and advise cross-functional teams on labeling, claims, and compliance to drive product commercialization.

The role requires a Master’s or PhD and 8-10+ years of regulatory affairs, with strong communication and project-management skills.

Qualifications

• Master's degree or Ph.D. in a related scientific discipline.
• 8-10+ years of progressive regulatory affairs experience.
• Experience supporting product commercialization, innovation initiatives, and global expansion.
• Experience developing regulatory strategies for new products, ingredients, or claims.
• Ability to influence stakeholders and manage multiple priorities.

Responsibilities

• 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.
• Advise cross-functional teams on regulatory implications of emerging technologies and business opportunities.
• Evaluate regulatory requirements and market access pathways for new geographic markets.
• Monitor changes in U.S. and global regulatory environments and recommend actions to maintain market access and growth.
• Oversee regulatory submissions, registrations, and authorization activities.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional collaboration

Project management

Global market access

Education

Master's or PhD in Food Science, Chemistry, Toxicology, Regulatory Science, Nutrition, Biochemistry, Pharmaceutical Sciences

Job description

Balchem Corporation in Montvale, NJ seeks a Manager, Regulatory to partner with R&D, Marketing and Quality to guide regulatory strategy, enable market access, and support global expansion. You will lead regulatory submissions, monitor developments, and advise cross-functional teams on labeling, claims, and compliance to drive product commercialization.

The role requires a Master’s or PhD and 8-10+ years of regulatory affairs, with strong communication and project-management skills.