Regulatory Manager

Position Summary

Principal Duties & Responsibilities

Leadership & Governance

• Lead and oversee the global Regulatory Affairs support function, leveraging SMEs to deliver timely, accurate customer responses and regulatory documentation.
• Supervise and develop regulatory and technical resources, including Senior-level technical contributors, to ensure capability, continuity, and scalability.
• Establish governance, prioritization, and performance standards for regulatory response workflows and document control.

Customer & Product Regulatory Affairs

• Own and manage the end-to-end regulatory response process for customers, including request intake, tracking, escalation, and delivery.
• Maintain, control, and approve all customer-facing regulatory documents, including product dossiers, cGMP attestations, FDA registrations, certifications (BSE, GMO, Halal, Kosher), ISO/QMS/FSSC documentation, and related technical statements.
• Serve as the primary HSM authority for product regulatory compliance, providing guidance across food additives, feed, cosmetics, nanomaterials, food contact, purity/specifications, automotive, construction, EU-REACH, and other global frameworks.
• Represent HSM in industry associations to influence emerging regulations and mitigate regulatory risk.

Registrations, SDS & Hazard Communication

• Ensure ongoing compliance and maintenance of key registrations and certifications, including NSF, FDA (Food/Feed/Pharma), state registrations, FSSC 22000, EU EDQM CEP, DMF, and other licenses.
• Serve as primary HSM lead for Hazard Communication, collaborating with Corporate/HEM Regulatory Affairs on SDS and labeling.
• Maintain proficiency in Wercs to provide backup leadership for SDS authoring and labeling compliance.

Quality & Compliance Integration

• Act as the QMS and cGMP Regulatory SME, educating cross-functional teams on regulatory expectations (ICH, CFRs, ISO/FSSC, USP).
• Support internal audits, Annual Product Quality Reviews, Change Control programs, and Management Review documentation.
• Ensure alignment between regulatory expectations and Quality systems across HSM facilities.
• Support electronic systems compliance including 21 CFR Part 11 considerations.

Business Partnership & Risk Management

• Proactively monitor regulatory changes and emerging trends; assess and communicate business risk and mitigation strategies.
• Partner with Innovation, Quality, Commercial, Supply Chain, and Corporate teams to enable compliant growth.
• Participate in the Huber RegWatch Network and other forums to foster enterprise alignment.
• Serve as LIMS System Administrator and support regulatory technology initiatives as needed.

Specialized/Technical Knowledge or Required Skills

• Master’s degree in Chemistry, Food Science, Food Law, or related discipline OR Bachelor’s degree with 7+ years of progressive Regulatory Affairs and/or QMS experience in food, feed, specialty ingredients, or regulated manufacturing.
• Proven experience leading or managing Regulatory Affairs functions in complex, multi-regulatory environments.
• Deep knowledge of cGMP and QMS frameworks (ISO 9001, FSSC 22000, ICH-Q7, relevant CFRs); Internal Auditor certification preferred.
• Strong understanding of global product regulatory requirements and registration management.
• Demonstrated leadership, project management, and cross-functional influence capabilities.
• Excellent written and verbal communication skills; strong customer-focused mindset.
• Proficiency in Microsoft Office (Excel, PowerPoint); Wercs and SDS authoring experience a plus.
• Ability to travel up to 30% as required.

Total Rewards

• J.M. Huber Corporation complies with all local/state regulations requiring salary range transparency.
• Any offered salary is determined based on relevant factors such as an applicant's skills, performance, job responsibilities, prior relevant experience, certain degrees and certifications and market considerations.
• | U.S. Market-Based Salary Range | | Regulatory Manager | [$96,900.00 - $135,000.00] |

Huber Benefits

• Huber also offers a comprehensive, competitive benefits package as detailed on the Huber Benefits Hub

Principles

• Our employees are our strongest asset, and their safety, health, and well-being is our highest priority. We respect the individual by providing opportunities for professional and personal development.

EEO Employer

• J.M. Huber Corporation is an EEO employer.

Drug Screening

• Pre-employment drug screening is required.