Product Development and Regulatory Manager
hace 10 días
Mount Bethel
Job Description PURPOSE To drive customer satisfaction and ensure ongoing regulatory and quality compliance, this role supports the development, collection, management, and distribution of all required product documentation. The position is actively engaged throughout the Product Development process—including project management tasks, product setup activities, cross‐functional coordination, and to ensure that all documentation is accurate, complete, and compliant. This job description will be reviewed annually or as needed. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Product Development Integration & Product Setup • Actively participate in the Product Development process, providing documentation expertise and support from concept through launch., • Lead and manage the new product setup process, ensuring all product details are accurately captured and communicated., • Collaborate with Product Development, Quality, and Operations to ensure product documentation aligns with formulation, regulatory requirements, manufacturing needs, and customer expectations. 2. Raw Material Regulatory & Quality Documentation Management • Obtain, review, assess, and maintain current regulatory and quality documents for all raw materials., • Support PD during new product ideation, alternate sourcing, ingredient evaluation, and supplier qualification by providing timely documentation and regulatory insights., • Provide critical risk and compliance assessment to Product Development and Quality based on documentation review., • Maintain ongoing documentation management to ensure cGMP compliance and safeguard product quality and consumer protection. 3. Product Documentation Development & Maintenance • Create, update, and version‐control product technical documents., • Ensure documentation accuracy and consistency with input from the Director of Product Development and Director of Quality. 4. Label Compliance Review • Conduct regulatory label and packaging reviews to ensure accuracy, compliance with applicable regulations, and alignment with product specifications. 5. Special Projects & Regulatory Documentation Initiatives • Serve as the internal expert and primary contact for documentation requests from WIN/Oceana Health customers and manufacturing partners., • Lead internal and customer‐facing documentation projects, ensuring accuracy, organization, and regulatory compliance., • Gather necessary documents and data to support foreign registration, international certifications, or customer‐specific regulatory requirements., • Contribute to process‐improvement initiatives related to documentation systems, workflows, and compliance readiness. 10 - 15% annual performance bonus PERSONNEL MANAGEMENT This position does not currently require the management of company personnel. OTHER QUALIFICATIONS General knowledge of Quality Management Systems and 21 CFR Part 111. QUALIFICATIONS EDUCATION AND EXPERIENCE • 5+ years of experience in the product development and/or regulatory/quality., • General understanding of regulatory documentation requirements. COMPUTER SKILLS To perform this job successfully, an individual must be knowledgeable of general office software. Proficient with MS Office Suite. Knowledge of SharePoint and /or other shared folder software. SKILLS AND ABILITIES • Product and Technical Knowledge, • General regulatory knowledge, • Project Management, • Data Analysis and Interpretation PERSONAL CHARACTERISTICS As an entrepreneurial company, WIN Nutrition/Oceana Health values: • Interpersonal Skills, • Customer Focus, • Innovation, • Integrity, • Operational Discipline, • Teamwork, • Humility
