Manager – Regulatory

Reports to:
GCOQ – Global Chief of Quality (Functional/Global Alignment)

Department: Quality Assurance / Quality Control
Supervises: Regulatory Associates, Technicians

Organizational Relationships:
QA/QC, Production, Warehouse, Engineering, R&D, Sales Project Managers, Account Executives, Operational Personnel, Customers, Regulatory Agencies, External Vendors/Suppliers, Global Quality Teams

Responsibility Summary: The Manager – Regulatory is responsible for supporting site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, raw material management, and cross-functional coordination to ensure full adherence to applicable global regulations.
The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership.

Responsibilities:

• Oversee issuance of Raw Material regulatory statements including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations.
• Direct vendor communication and ensure timely collection and verification of regulatory documentation.
• Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements.
• Support regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs.
• Oversee regulatory compliance documentation generated through internal and third-party systems.
• Conduct regulatory review of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans.
• Support the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMF), and global regulatory submissions.
• Support preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits.
• Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, TGA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations.
• Support regulatory-related SOP development, Change Control, and QMS compliance.
• Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance.
• Provide regulatory leadership guidance to cross-functional teams and support global quality initiatives.
• Act as regulatory delegate for the site, as required.

Qualifications:

• Bachelor’s Degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of regulatory experience in pharmaceutical, cosmetic, medical device, food or related regulated industry
• Working knowledge of FDA regulations (21 CFR 210, 211, 820)
• Strong leadership, cross-functional influence, and communication skills
• Analytical and regulatory risk assessment capability

Compensation & Benefits:

• The approximate pay range for this position is $75,000 to $90,000 per year. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities.
• Benefits:

o Medical, Dental, Vision, Life
o PTO
o Special Paid Leave for employees’ personal events
o Company Paid Holidays
o 401(k) employer match
o Year-End Gift

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