Regulatory Specialist II
Job Details
- Job Ref:
- REGUL004322
- Location:
- 2224 Atlanta Hwy SW, Gainesville, GA 30504
- Category:
- Regulatory Affairs
- Employment Type:
- Full Time
Overview
When Alfred Fain founded a small Rhode Island tire store in 1924, at the time no one could have predicted how Teknor Apex would become an international custom compounder sought out by companies around the world. After a nearly hundred-year journey that’s carried us through acquisitions and expansion, we now have nine U.S. locations, as well as operations in Belgium, Singapore, Germany, and China.
Throughout this global expansion Teknor has remained a privately held company, and today Fain’s grandson sits at the helm, maintaining the family’s tradition of fostering deep employee and customer relationships. These relationships are what allow us—together—to deliver customized compound solutions and help our customer’s create better products.
“Manufacturing is a team sport, and we work together to achieve our goals.” ~Jon Fain
Position Summary
Teknor Apex is seeking a Regulatory Specialist to join our Corporate Regulatory Affairs team. We are preferably seeking an experienced regulatory professional, but we are open to qualified candidates ranging from entry level to 15+ years of experience.
This role supports domestic and international regulatory compliance for finished goods across all Teknor Apex divisions. The Regulatory Specialist serves as a key technical resource for internal stakeholders, customers, regulatory agencies, and third-party certification organizations. Level, scope, and leadership expectations will be aligned to the selected candidate’s experience.
Key Responsibilities
Depending on experience level, responsibilities may include some or all of the following:
- Provide regulatory compliance information to customers, government agencies, and third-party certification organizations for domestic and international markets
- Interpret existing U.S. and global regulations and assess their impact on Teknor Apex products and businesses
- Issue regulatory certification letters and compliance statements for external customers
- Maintain corporate product formula restriction programs and authorize formula revisions
- Support or lead regulatory impact assessments for new products, markets, and regulations
- Serve as a point of contact or internal coordinator for regulatory agencies (e.g., FDA, NSF, UL, EPA, OSHA, DOT, state and international agencies)
- Respond to customer inquiries related to regulatory compliance and documentation
- Maintain ongoing communication with internal customers and cross-functional teams
- Develop and deliver regulatory presentations or training for internal stakeholders and, when appropriate, external customers
- Utilize regulatory databases, ERP systems, and SDS authoring tools to support compliance activities
- Mentor or provide guidance to junior regulatory staff (for more senior-level candidates)
- Ensure compliance with all company policies, procedures, and applicable regulations
- Perform additional duties as assigned
Qualifications & Experience
We encourage candidates with varying levels of experience to apply. The role level and scope will be determined based on qualifications.
Education
- Bachelor’s degree or equivalent experience in chemistry, biology, toxicology, engineering, or a related scientific discipline
- Advanced degree preferred for senior-level candidates
Experience (flexible based on level)
- Entry level to 15+ years of regulatory affairs experience
- Experience interpreting and applying domestic and global product regulations
- Experience working with regulatory agencies and third-party certification organizations preferred
- Experience with new substance notifications or registrations (U.S. and/or international) preferred for senior-level candidates
- Experience with ERP systems (M3 preferred)
- Experience with regulatory databases and SDS authoring systems; GHS SDS authoring experience strongly preferred for experienced candidates
Skills
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Ability to develop compliance plans for new or revised regulations
- Ability to work independently and collaboratively in cross-functional teams
- Strong attention to detail and documentation practices
Physical Requirements:
- Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
- Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
- Ability to perform duties under specific time requirements
- Ability to adapt to changing duties and responsibilities
- Must be able to talk, listen and speak clearly on telephone
This description is a summary of principal responsibilities and is not intended to include all duties that may be assigned.
Teknor Apex is an equal opportunity employer and does not discriminate against any protected status under state or federal laws. Must be 18 years of age or older to work at Teknor Apex.
