Regulatory Manager

The Regulatory Affairs Manager leads the global regulatory affairs function for Huber Specialty Minerals (HSM), ensuring regulatory compliance, audit readiness, and proactive risk management across pharmaceutical, food, personal care, automotive, polymers, and industrial applications. This role is strategic and business‑critical, serving as the primary authority for product regulatory compliance, customer regulatory responses, registrations, and QMS/cGMP integration. Partnering closely with Innovation, Quality, Technical Services, and Corporate Regulatory teams, the Regulatory Affairs Manager protects the company’s license to operate while enabling growth, innovation, and customer trust globally.

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.

• 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.

In addition to base compensation, individuals may be eligible for an annual discretionary bonus and profit-sharing payout.

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