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 Practice (cGMP) 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.
Duties and Responsibilities
- 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 for labeling under review and communicating these to account managers and senior management as appropriate.
- 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 (cGMP) and other quality issues, and communicating them as appropriate.
- Write and maintain Standard Operating Procedures (SOPs) related to the Regulatory functional area. As needed, may review and contribute to crossfunctional SOPs.
- Establish and maintain regulatory archives in compliance with applicable regulatory requirements.
- As needed, works 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.
Qualifications, Knowledge, Skills, & Abilities
- Bachelor’s Degree in a Scientific field.
- 5 years’ experience in regulatory and compliance within the food/pharmaceutical industry.
- 2 years’ experience in a leadership role.
- Knowledge of applicable regulatory requirements.
- Knowledge and experience in interpreting and applying FDA and FTC regulations, policies, and procedures.
- Basic knowledge of human resource practices.
- Advanced skill in verbal and written communication.
- Intermediate skills with Microsoft Excel, Word, PowerPoint, and Outlook
- Basic skill in Microsoft SharePoint
- 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.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.