Regulatory Assurance Specialist

We are looking for a Regulatory Assurance Specialist to support and manage supplemental registrations for Arxada and affiliated organizations, ensuring compliance with regulatory standards and delivering a seamless experience to clients and stakeholders.

Requirements

• Maintain up-to-date knowledge of relevant regulatory requirements, policies, and procedures
• Primary point of contact for customer supplemental registrations
• Prepare, submit, and monitor applications for supplemental registrations, label updates, with regulatory authorities
• Ensure customer/3d party agreements/ documentation meets internal (Arxada Quality Management System) and external compliance standards
• Liaise with regulatory agencies, business stakeholders, and customers to ensure timely approvals and resolve issues
• Support internal and regulatory agency audits
• Clearly communicates in a timely manner
• Ensure all client interactions are professional and empathetic
• Execute process improvement

Benefits

• 401(k) plan
• medical
• dental
• vision
• life
• disability insurance
• paid time off
• paid holidays
• paid sick leave