• Apex Systems
  • $168,200.00 -168,200.00/year*
  • Legal
  • Full-Time

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The Regulatory Compliance Manager is responsible for managing the regulatory aspects of innovative products and services for Santa Cruz Nutritionals (SCN). The individual must effectively collaborate with members of Quality Assurance (QA), Quality Control (QC), Change Control, Sales, Marketing, and Research and Development (R&D) to assure products and services are planned and implemented compliant, with current Good Manufacturing Practices (GMP) and other applicable regulatory requirements. As needed, may work with legal counsel to determine suitability of labeling and other practices as they relate to applicable regulatory requirements.

  • Oversees the regulatory compliance assessment of new and revised product labeling. Responsible for any communications around these with health authorities
  • Responsible for the identification of legal risks regarding product labels and communicating these to sales and marketing, as well as the executive management team as needed
  • Work with the Quality unit to manage audits by regulatory authorities and any resultant preventive and corrective action (CAPA) plans
  • Provide regulatory input and feasibility assessments for new product development efforts
  • Responsible for keeping current on applicable regulatory requirements affecting current Good Manufacturing Practice (GMP), related to 21CFR:110, 111, 117
  • Write and maintain Standard Operating Procedures (SOPs) related to the Regulatory functional area. As needed, may review and contribute to cross functional SOPs
  • Establish and maintain regulatory archives in compliance with applicable regulatory requirements
  • Work with other departments to develop sound quality agreements, product dossiers, and label agreements
  • Responsible for all filings to regulatory authorities (e.g., site licensing for Health Canada)
  • Provides Regulatory support of Supplier Development including the performance of supplier quality system audits, and assisting suppliers to meet compliance requirements
  • Oversees the efforts of direct reports and is responsible for their work outcome and personal development
  • Maintains professional and technical knowledge by attending education workshops and reviewing professional publications
  • Other duties as assigned

Minimum Qualifications

  • Bachelors Degree in Chemistry, Chemical Engineering, Biology, or Mathematics
  • 5+ years experience in regulatory compliance within the food/pharmaceutical/dietary supplement industry
  • 2+ years experience with FDA and FTC regulations, policies, and procedures
  • 2+ years experience in a leadership role
  • 5+ years experience with Microsoft Excel, Word, PowerPoint, and Outlook

Preferred Qualifications

  • Advanced skill in verbal and written communication
  • Basic skill in Microsoft SharePoint
  • Basic knowledge of human resource practices
  • Knowledge of applicable regulatory requirements
  • Self-starter with strong, proactive work ethic
  • High level of attention to detail
  • Ability to manage multiple projects simultaneously to meet deadlines
  • Ability to collaborate and influence cross-functional colleagues
  • Project management experience preferred

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-###-####

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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