Founded in the 1980s and rebranded in 2017, we are a privately held chemical and ingredients distribution leader across North America serving markets such as care, food & nutrition, industrial specialties, and life sciences. 

We are seeking a Regulatory Affairs Coordinator / Specialist to play a crucial role in ensuring that our products comply with all applicable regulations and standards in the US and CAN. This position involves working closely with cross-functional teams to facilitate the regulatory submission process and maintain compliance throughout the product lifecycle.

Key Responsibilities

• Coordinate and manage regulatory submissions for medical devices and pharmaceuticals.
• Develop and maintain documentation in accordance with FDA regulations and quality assurance standards.
• Assist in the preparation of submissions for clinical trials and other regulatory milestones.
• Collaborate with project management teams to ensure timely delivery of regulatory requirements.
• Monitor changes in regulations to ensure compliance with federal, state, and international laws.
• Support the development and maintenance of Standard Operating Procedures (SOPs) related to regulatory affairs.
• Conduct risk management assessments to identify and mitigate potential compliance issues.
• Communicate effectively with regulatory agencies and internal stakeholders to facilitate approvals and address inquiries.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field
• 3+ years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industries
• Strong understanding of FDA regulations, FSMA, TSCA, and other relevant safety and compliance standards
• Experience with submission processes for clinical trials and product clearances
• Excellent communication skills, both written and verbal, for effective cross-functional collaboration
• Proficiency in project management and organizational skills to handle multiple priorities efficiently
• Familiarity with electronic submission portals such as CDER Direct and other agency systems
• Knowledge of relevant safety data sheets (SDS) and hazardous materials regulations (DOT, OSHA)

Benefits

• Comprehensive healthcare, 401(k) matching, and more
• Hybrid work schedules (3 days in office after 90 days)
• Access to learning opportunities and resources to grow in your career
• Be part of a diverse, collaborative, and supportive team
• Work with top brands in a dynamic field and contribute to meaningful growth