Regulatory Affairs Specialist

Reese Consumer Health•Cleveland, OH

12d

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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