Regulatory Affairs Specialist

Regulatory Affairs Specialist Reese Pharmaceutical - 4.3 Cleveland, OH Job Details 18 hours ago Qualifications Manufacturing Manufacturing company experience Full Job Description At Reese Consumer Health, we put Consumers First! Our diverse product portfolio includes category leading brands such as Reese's Pinworm®, Reese's Colotest® and new brands such as LiceGuard® As Reese focuses on an aggressive growth strategy, we are looking for a technical and insight driven Assistant Controller to help take our business to the next level. Founded in 1907 and headquartered in Cleveland, Ohio, Reese Consumer Health is a consumer-first, insight-driven company with nearly 120 years of expertise in manufacturing, marketing, and collaborating with retailers. Reese helps organizations create innovative OTC products and supplements, leveraging deep industry knowledge to deliver high-quality solutions across the healthcare sector. With an expanding portfolio of brands, Reese is committed to driving consumer health innovation through omnichannel strategies that reach a wide range of consumers across multiple retail and distribution channels.

Incorporating our company values:

Accountability, Continuous Improvement, Consumer Focus, Integrity, and Quality. As a member of the Quality Assurance department, maintain and improve the company Quality Management Systems. The Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist is responsible to assist in problem identification and resolution, and improvement of the regulatory infrastructure in Quality, Operations, and third-party.

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

EDUCATION / EXPERIENCE

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.

QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

OTHER RESPONSIBLILTIES

Provide mentorship for Regulatory, Quality Assurance, and other personnel regarding Good Manufacturing Practices and regulatory principles. We are an Equal Employment Opportunity Employer.