Regulatory Compliance Manager

Quality Assurance Santa Cruz, California


Description

We are seeking an experienced Regulatory Compliance Manager to join our growing organization. The Regulatory Compliance Manager is responsible for managing the regulatory aspects of new product innovation, existing product changes or updates and acting as a service individual/department, for the Santa Cruz Nutritionals (SCN), Santa Cruz site. This individual must effectively collaborate with members of the Quality Unit, Engineering and Maintenance, Sales, Marketing, Supply Chain and Research and Development (R&D) to assure products and services are planned and implemented in a compliant manner, with current Good Manufacturing Practices (cGMP) and other applicable regulatory requirements.   As needed, this individual will work with legal counsel, both internal and external, 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 and regulatory authorities
  • Responsible for the development of structure function claim documentation to support product labeling claims
  • Responsible for the identification of legal risks regarding product labels and communicating these to sales and marketing, as well as the Senior Management team, as needed
  • Provide regulatory input and feasibility assessments for new product development efforts
  • Manage audits by regulatory authorities, customers, as well as third-party certification bodies, and provide oversite of any resultant preventive and corrective action (CAPA) plans
  • Manage SCN’s CAPA, and internal audit program
  • Responsible for keeping current on applicable regulatory requirements affecting current Good Manufacturing Practice (cGMP), related to 21CFR:110, 111, 117 and translating these requirements into SCN policies and procedures
  • 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 and the SME, to develop sound quality agreements, product dossiers, and label agreements
  • Responsible for all filings to regulatory authorities (e.g., site licensing for Health Canada, biannual FDA registration, etc.)
  • 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

  • Bachelor’s degree in law, business administration, Food Science, or a related field
  • 5+ years’ experience in a leadership role within a quality organization (QA/QC/Regulatory)
  • 3+ years’ experience in regulatory compliance within the food/pharmaceutical/dietary supplement industry
  • 3+ years’ experience with FDA and FTC regulations, policies, and procedures
  • Must always demonstrate adherence to ethical standards
  • Business acumen, innovation, strategic thinking, professionalism, visionary leadership and problem-solving skills are critical, as it relates to execution, to be the successful candidate
  • Must pay attention to detail and work independently using sound judgment, legal research and organizational skills
  • Experience with assisting or managing GMP QA audits and inspections as well as interfacing with regulatory agencies

Preferred Qualifications

  • Excellent verbal and written communication skills; able to write and edit company policies
  • Encouraging to team and staff; able to mentor and lead regulatory team members
  • Goal-oriented, organized team player
  • Accurate and precise attention to detail
  • Basic skill in Microsoft SharePoint
  • Basic knowledge of human resource practices
  • Knowledge of applicable regulatory requirements
  • Self-starter with strong, proactive and dedicated 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

 

Physical Requirements

While performing the duties of this job, the employee is regularly required to work in a stationary position, may move from one area to another, frequently operates a computer/office equipment, and frequently communicates with others. The employee may frequently lift and/or move up to 10 pounds and occasionally move and/or lift or move up to 25 pounds.

 

EEO statement

All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status