Hospeco Brands Group
Company Overview
Hospeco Brand Groups (Tranzonic Companies) is thehubfor astrategic collectionof manufacturing and salescompaniesthat lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empowerits distributor partners into the future.Their cohesive approach promotesoperational efficiency andfuelsinnovation,whileequipping 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, ispoweredbyitsteam ofdriven, innovative problem-solvers and a culture of integrity and respect. Position Summary
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. Essential Functions and Responsibilities
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. Requirements
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.
#J-18808-Ljbffr
Hospeco Brand Groups (Tranzonic Companies) is thehubfor astrategic collectionof manufacturing and salescompaniesthat lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empowerits distributor partners into the future.Their cohesive approach promotesoperational efficiency andfuelsinnovation,whileequipping 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, ispoweredbyitsteam ofdriven, innovative problem-solvers and a culture of integrity and respect. Position Summary
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. Essential Functions and Responsibilities
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. Requirements
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.
#J-18808-Ljbffr