Regulatory Compliance Specialist

Position Summary:

The Regulatory Compliance Specialist ensures adherence to regulatory compliance requirements for Bell International Laboratories. Register and maintain NDCs, registrations with the FDA, Health Canada, and EU Regulatory Agencies 

Responsibilities

• Support customers by providing regulatory reviews of customer labeling.
• Provide Bell and our customers with regulatory guidance for FDA, Health Canada, and EU OTC and Cosmetic requirements
• Register and maintain NDC’s with the FDA.
• Register and maintain customer NDC’s with the FDA.
• Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards.
• Maintain regulatory approvals and associated files. Build and maintain “regulatory library” using The Good Face Software.
• Provide regulatory feedback to R&D regarding proposed product ingredient lists. 
• Support R&D during development process to ensure formulas are compliant in the applicable regulated countries. 
• Identify and create efficiencies in the facilitation of regulatory processes. 
• Register and maintain Bell’s FDA Registration as an OTC manufacturer.

Required Skills/Abilities

• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines. 
• Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment. 
• Strong organizational skills, with a keen eye for reviewing and editing documents. 
• Ability to maintain meticulous attention to detail and precision while juggling multiple tasks. 
• Excellent written, verbal and interpersonal communication skills.
• Proficiency in Microsoft Office and Adobe Acrobat.

Required Education and Experience

• BS/BA in science, engineering, quality/regulatory studies, or equivalent industry experience in pharmaceutical regulatory affairs.
• 2 years of OTC/Cosmetic regulatory experience with FDA, including FDA NDC registrations for OTC pharmaceuticals and/or cosmetics.

Preferred Education and Experience

• Master’s degree in science, engineering, quality/regulatory studies, or equivalent industry experience in pharmaceutical and cosmetic regulatory affairs.
• 3-5 years of OTC/Cosmetic regulatory experience with FDA, including FDA NDC registrations for OTC pharmaceuticals and/or cosmetics.
• Experience with Health Canada and EU OTC/Cosmetics regulations.

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.