Description

Position Summary:

The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements. 

Responsibilities

• Support our customers through provision of requested regulatory documentation. 
• Coordinate and prepare routine submissions for FDA and other regulatory entities. 
• Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards. 
• Maintain regulatory approvals and associated files. Build and maintain “regulatory library”. 
• Provide regulatory feedback to R&D regarding proposed product ingredient lists. 
• Evaluate customer artwork for adherence to regulatory compliance. 
• 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. 
• Actively participate in internal audits, customer audits and other activities as assigned by manager.

Requirements

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. 
• A quality professional with 2-5 years of hands-on experience in regulatory management within the regulated pharmaceutical industry, including direct regulatory experience. 

Preferred Education and Experience

• Exhibit a quality mindset and a willingness to develop yourself and others. 
• Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance. 
• Audit or inspection experience preferred. 

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.