Regulatory Affairs Specialist

Quality Assurance Santa Cruz, California


Description

The Regulatory Affairs Specialist I, as a member of the Regulatory Affairs (RA) Department, is responsible for maintaining compliance with applicable regulations such as FDA, USP, NSF, QAI, etc. Responsible for the application, maintenance and support of product certification programs in collaboration with Marketing, R&D and Quality, as needed. Key responsibilities include maintaining all current and future third-party certifications including organic, gluten free, Kosher, non-GMO, NSF and USP. The Regulatory Affairs Specialist I reviews and authorizes label and packaging for claim substantiation, develops structure/function claim substantiation in conjunction with applicable departments or third parties and monitors FDA and other applicable regulations for changes and advises of potential impact to the company.

 

Duties and Responsibilities

  • Plan, coordinate, facilitate and document reports on the company's regulatory programs.
  • Develop, prepare and submit applications and notifications to regulatory agencies and certifying bodies.
  • Ensure compliance with relevant regulations.
  • Coordinate and report on internal regulatory processes, such as internal audits, inspections, license renewals and registrations.
  • Manage the regulatory review of design, manufacturing, labeling and specification changes.
  • Serves as liaison between the organization and regulatory authorities in the process of obtaining product approval or clearance.
  • Review change orders and assess impact of product changes on regulatory strategy and submissions per standard procedures.
  • Make recommendations on the development of regulatory strategies, obtain approvals and implement as required throughout the product life cycle.
  • Monitor and ensure company is informed of current regulatory requirements.
  • Participate in product innovation teams, providing regulatory guidance and timeframe estimates.
  • Review and revise labeling, training, promotional and advertising material.
  • Provide regulatory training to staff, as needed.
  • Support post-market regulatory compliance activities for product approvals.
  • Develop and maintain RA procedures.
  • Maintain RA files and regulatory correspondence log.
  • Perform label review to verify substantiation of claims and build/maintain claims substantiation library.

 

Required Qualifications

  • Bachelor’s degree in biology, chemistry or related field.
  • 2 years’ experience in the food, dietary supplement or drug industry.
  • Proficiency with Microsoft Office including Excel, Outlook and PowerPoint.
  • Strong mathematical, analytical, detail-orientation, organizational and collaboration skills.
  • Solid verbal, written, and interpersonal communication skills.

 

Preferred Qualifications

  • Master’s degree in a related field.
  • Regulatory Affairs Certification (RAC).
Regulatory, Consumer Packaged Goods (CPG), Good Manufacturing Practices (GMP) and/or manufacturing experience.