Regulatory Manager

Jobtailor; Montvale (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Paid time off

Job summary

Jobtailor is seeking a seasoned regulatory affairs expert to serve as a trusted advisor to business partners and cross-functional teams on market access, product positioning, regulatory risk, and commercialization opportunities.

You will guide strategic planning, portfolio management, and partnerships, assess regulatory developments, and oversee submissions and global registrations to sustain market access and growth.

Qualifications

• Advanced degree in a relevant science field with regulatory expertise.
• 8-10+ years of progressive regulatory affairs experience.
• Experience supporting product commercialization and global market expansion.
• Strong cross-functional collaboration with senior stakeholders.

Responsibilities

• Serve as a trusted regulatory advisor to cross-functional teams on market access and regulatory risk.
• Assess regulatory developments and advise on business impacts.
• Oversee regulatory submissions, registrations, and authorization activities.
• Support integration activities for acquisitions and partnerships.
• Build regulatory pathways for new products and claims.
• Monitor U.S. and global regulatory environments to maintain market access.
• Review claims, labeling, documentation, and marketing materials for compliance.

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

Excellent Communication Skills

Analytical Abilities

Organizational Skills

Influencing Skills

Relationship Management

Education

Master's degree or Ph.D. in Food Science, Chemistry, Toxicology, Regulatory Science, Nutrition, Biochemistry, Pharmaceutical Sciences, or related field

Job description

• 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