Strategic Regulatory Leader - Global Market Access

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 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.