Quality Assurance Regulatory Specialist

2 weeks ago

Valencia, California, United States Lief Labs Full time

Lief Labs stands as a leading innovator in formulation and product development, specializing in dietary supplements. Our dedicated Product Development and R&D teams are committed to creating exceptional and innovative supplement formulations. We also operate a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) facility, providing tailored solutions across various supplement categories. Lief Labs partners with entrepreneurial firms to cultivate premier brands, offering seamless turnkey solutions that promote scalability and sustainable growth. All positions at Lief Labs are conducted on-site during standard business hours.

Position Overview

The Quality Regulatory Affairs Specialist is tasked with ensuring adherence to regulatory standards and requirements governing the production and distribution of dietary supplements. This role involves close collaboration with cross-functional teams to support regulatory submissions, maintain essential documentation, and ensure compliance with quality standards throughout the product lifecycle.

Key Responsibilities

  • Regulatory Compliance: Remain informed about changes in regulations affecting dietary supplements, including FDA guidelines and cGMPs, ensuring that products meet all relevant compliance standards.
  • Documentation Management: Develop, review, and uphold regulatory documentation, including product dossiers and technical files, ensuring all records are accurate and well-organized.
  • Labeling and Packaging Compliance: Evaluate product labeling and packaging to confirm compliance with regulatory requirements, including ingredient listings and health claims.
  • Regulatory Submissions: Aid in the preparation and submission of regulatory filings to agencies, including new product registrations and ingredient notifications.
  • Quality Assurance Support: Collaborate with quality assurance teams to create and implement processes that monitor and maintain product quality throughout manufacturing and distribution.
  • Cross-Functional Collaboration: Work alongside internal departments, including R&D, manufacturing, marketing, and legal, to support regulatory initiatives and resolve compliance issues.
  • Audits and Inspections: Participate in regulatory audits and inspections, assisting in the preparation of responses and implementation of corrective actions as necessary.
  • Regulatory Intelligence: Track regulatory developments and industry trends to evaluate their potential impact on product compliance and strategy.
  • Training and Education: Provide training to internal stakeholders on regulatory requirements and quality standards.
  • Perform additional duties as assigned.
Supervisory Responsibilities

None

Minimum Qualifications

Education

Bachelor's degree in a relevant field (e.g., regulatory affairs, life sciences, chemistry, or pharmacy). An advanced degree is preferred.

Experience
  • 3-5 years of experience in regulatory affairs, particularly within the dietary supplement or pharmaceutical industry.
  • Strong understanding of regulatory processes and quality standards.
  • Knowledge of cGMP, FDA regulations, and quality control practices.
Skills and Abilities
  • Leadership
  • Problem Solving
  • Planning and Organizing
  • Effective Communication
  • Relationship Management
  • Quality Orientation
  • Team Collaboration
  • Adaptability
Work Environment

The office is maintained in a clean and orderly manner, with low to moderate noise levels. Field conditions may vary.

Exposed to various raw materials, including allergens.

Physical Demands

Employees may need to bend, sit, talk, and move about frequently. Lifting and moving up to 20 pounds may be required. Must be able to stand for extended periods and work independently or as part of a team.

Additional Information
The salary range for this position is competitive and commensurate with experience. Benefits include medical, dental, vision, 401(k), life insurance, wellness programs, education reimbursement, and paid time off. This position is eligible for bonuses. Lief Labs is an Equal Opportunity employer, and all qualified applicants will receive consideration for employment without regard to any protected characteristic.

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