Regulatory Affairs Manager

Regulatory Affairs Manager – The Tranzonic Companies Company Overview

Hospeco Brand Groups (Tranzonic Companies) is the hub for a strategic collection of manufacturing and sales companies that lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empower its distributor partners into the future. Their cohesive approach promotes operational efficiency and fuels innovation, while equipping its varied businesses to tackle the toughest challenges across industrial and manufacturing, healthcare and life sciences, food service, hospitality, transportation, and many other dynamic market segments.

Hospeco Brand Group’s rapid growth, both organic and via acquisition, is powered by its team of driven, innovative problem-solvers and a culture of integrity and respect.

The Regulatory Affairs Manager oversees and manages all regulatory activities within our organization. The ideal candidate will have a strong understanding of regulatory requirements pertaining to the many regulatory bodies that govern our business. These bodies include but are not limited to the FDA, EPA, Health Canada, NHP, cGMP, ISO and GDP. Candidates will need to demonstrate a strong track record of successfully navigating a complex regulatory landscape across multiple commodities while maintaining good standard operating procedures.

• Develop and implement strategies to ensure compliance with local, state, national, and international regulations governing the production, labeling, distribution, and disposal of chemical products.
• Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and legal, to ensure regulatory compliance throughout the product lifecycle.
• Conduct regulatory assessments of new products, ingredients, and processes to identify potential compliance issues and mitigate risks.
• Maintain accurate and up-to-date regulatory documentation and records, including product dossiers, safety data sheets (SDS), and technical files.
• Prepare and submit regulatory filings, registrations, notifications, and certifications to relevant regulatory authorities.
• Lead corrective and preventive action (CAPA) efforts as assigned.
• Serve as the primary point of contact for regulatory agencies by responding to inquiries, requests for information, and inspections in a timely and professional manner.
• Monitor regulatory developments, assess their potential impact on the company, and determine actions needed.
• Participate in industry associations, trade groups, and regulatory forums to stay abreast of best practices and emerging trends in regulatory affairs.
• Develop and deliver regulatory training programs to employees to ensure understanding and adherence to regulatory requirements.
• Proactively identify opportunities for process improvements and efficiency gains within the regulatory function.

• Bachelor's degree in chemistry, chemical engineering, regulatory affairs, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the chemical industry, with a strong understanding of regulatory requirements in multiple jurisdictions.
• Demonstrated knowledge of relevant regulations, including but not limited to FDA, EPA, Health Canada, NHP, cGMP, ISO and GDP, GHS DOT, GUDID, TSCA, REACH, CLP, and other chemical control laws and regulations.
• Proven ability to interpret and apply complex regulatory requirements to business operations and product development.
• In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR.
• Excellent communication skills, with the ability to effectively communicate technical and regulatory information to internal and external stakeholders.
• Strong project management skills, with the ability to prioritize tasks, manage deadlines, and lead cross-functional teams.
• Detail-oriented and analytical mindset, with a focus on accuracy and compliance.
• Ability to adapt to changing regulatory landscapes and proactively identify opportunities and risks.
• Experience interacting with regulatory agencies and industry organizations preferred.
• Professional certifications in regulatory affairs (e.g., RAC) are a plus.
• 15% travel expected.

Mid-Senior level

Full-time

Legal

Wholesale