Regulatory Affairs Specialist

RESPONSIBILITIES / DUTIES

• Support and maintain QMS systems in compliance with GMP, FDA, and other regulatory requirements.
• Communicate quality issues/trends to management and identify appropriate resolution.
• Assist with quality audits and regulatory inspections, including development and implementation of responses to observations.
• Lead investigations using root cause analysis and sound technical writing.
• Assist with Supplier Qualification and management including onboarding and evaluation.
• Maintain Non-conformances, CAPAs, and other documentation in the Quality Management System.
• Complete documentation including bi-annual review of procedures, annual product reviews, change control / change management, risk assessments, and validation activities.
• Maintain customer, supplier, and other external portals and provide support for technical inquiries.
• Identify gaps in regulatory framework per 21 CFR 210/211, 111, and 820 and suggest improvements.
• Provide technical expertise to support cross-functional initiatives. Contribute to continuous improvement and operational excellence projects.
• Participate in internal audits, supplier audits, and regulatory inspections.
• Perform regulatory review of labelling and artwork per CFR, customer specification, and other applicable requirements.
• Act as the subject matter expert for regulatory framework of assigned project areas.
• All other duties assigned

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific field
• 3+ years of experience in pharmaceutical Regulatory Affairs, Quality Assurance, or similar position within a regulated manufacturing environment.

• Strong knowledge of GMP, FDA, EU MDR, ICH, and regulatory compliance requirements
• Experience with deviation investigations, CAPA management, and change control systems
• Familiarity with pharmaceutical manufacturing processes and quality systems
• Strong analytical, organizational, and communication skills
• Ability to manage multiple priorities in a fast-paced environment
• Proficiency with quality management systems and Microsoft Office applications
• Knowledge of inspection and control methods, techniques, and documentation.
• Must be able to lift up to 20 pounds and stand for prolonged periods of time

• Experience supporting regulatory inspections or audits
• Knowledge of data integrity requirements and electronic quality systems
• Lean, Six Sigma, or continuous improvement experience
• Experience leading validation and qualification activities

• Provide mentorship for Regulatory, Quality Assurance, and other personnel regarding Good Manufacturing Practices and regulatory principles.

We are an Equal Employment Opportunity Employer.