Something is up on the West Side of Santa Cruz California besides the world-famous surf. Santa Cruz Nutritionals (SCN), THE Gummy Innovator, has invested $95 Million in all aspects of the business to drive Breakthrough Growth. SCN is pioneering innovative solutions in vitamin, mineral and supplements including probiotics, calcium, joint health, sports nutrition, immunity, sleep formulas, and fiber gummies. SCN sells over 350 unique formulas of gummy products and launched over 50 new products in the past 12 months alone.
Santa Cruz Nutritionals is one of the top 3 private-sector employers in Santa Cruz County. We are looking for talented individuals to join our team to help accelerate our transformation and drive the next wave of growth.
Duties and Responsibilities
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
Bachelor’s 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
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
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.
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
Internal Number: 0001
About Santa Cruz Nutritionals
Headquartered in Santa Cruz, CA with operations in Montreal, Canada, Santa Cruz Nutritionals (SCN), THE Gummy Innovator has invested $95 Million in all aspects of the business to drive Breakthrough Growth.
SCN is pioneering innovative solutions in vitamin, mineral and supplements including probiotics, calcium, joint health, sports nutrition, immunity, sleep formulas, and fiber gummies. SCN sells over 350 unique formulas of gummy products and launched over 50 new products in the past 12 months alone.
With over 500 employees, Santa Cruz Nutritionals is one of the largest private-sector employers in Santa Cruz County. Our employees enjoy the beauty of Santa Cruz as we are located just blocks from the beach and Natural Bridges State Park. We offer a generous benefits package including Medical, Dental, Life Insurance, Flex Spending Account, Company Match on 401K Plan, as well as, paid vacation and 12 Holidays. We are looking for talented individuals to join our team to help accelerate our transformation and drive the next wave of growth.
Santa Cruz Nutritionals is always looking for dynamic and detail-orientated individuals to join our team.