Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements.
Our in-house Product Development and R&D team create the best-tasting and most cutting-edge formulations of supplements.
Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories.
Lief collaborates with entrepreneurial firms to help them build premier brands.
Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth.
Lief Labs is located in the Santa Clarita Valley (Valencia, CA.) All roles are on-site Monday - Friday.
Summary
The Quality Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory standards and requirements governing the production and distribution of dietary supplements.
You will work closely with cross-functional teams to support regulatory submissions, maintain regulatory documentation, and facilitate adherence to quality standards throughout the product lifecycle.
Responsibilities Regulatory Compliance: Stay updated on regulatory changes and requirements related to dietary supplements, including FDA regulations, cGMPs, and other applicable guidelines.
Ensure product compliance with relevant regulations. Documentation Management: Prepare, review, and maintain regulatory documentation, including product dossiers, technical files, and regulatory submissions.
Ensure accuracy, completeness, and organization of regulatory records. Labeling and Packaging Compliance: Review product labeling and packaging materials to ensure compliance with regulatory requirements, including ingredient listings, health claims, and nutritional information. Regulatory Submissions: Assist in the preparation and submission of regulatory filings and notifications to regulatory agencies, including new product registrations, ingredient notifications, and labeling updates. Quality Assurance Support: Collaborate with quality assurance teams to develop and implement processes for monitoring and maintaining product quality throughout the manufacturing and distribution processes. Cross-Functional Collaboration: Work closely with internal departments, including research and development, manufacturing, marketing, and legal, to support regulatory initiatives and address compliance issues. Audits and Inspections: Participate in regulatory audits and inspections.
Assist in the preparation of audit responses and implementation of corrective actions as needed. Regulatory Intelligence: Monitor regulatory developments, industry trends, and competitor activities to assess potential impact on product compliance and regulatory strategy. Training and Education: Provide training and education to internal stakeholders on regulatory requirements, quality standards, and best practices. Perform additional duties as assigned Supervisory Responsibilities
none
Minimum Qualifications Knowledge Education:
Bachelor's degree in a related field (e.g., regulatory affairs, life sciences, chemistry, or pharmacy).
Advanced degree preferred.
Experience 3-5 years of experience as a machine operator specifically on encapsulation equipment, with 2 years in a lead or supervisory role, preferably in the pharmaceutical or dietary supplement industry. Strong understanding of encapsulation equipment, processes, and quality standards. Knowledge of cGMP, FDA regulations, and quality control practices in a manufacturing environment.
Skills/ Abilities Leadership Problem Solving Planning & organizing Verbal Communication Written Communication Relationship Management Quality Orientation Ability to interact at all levels Ability to work as a team member Flexibility/ adaptability/ multi-tasking Knowledge Minimum of 3 years of experience in regulatory affairs within the dietary supplement, pharmaceutical, or related industry. Knowledge of FDA regulations, cGMPs, and other relevant regulatory requirements for dietary supplements. Strong attention to detail and organizational skills. Excellent communication and interpersonal skills. Ability to work effectively in a cross-functional team environment. Proficiency in Microsoft Office applications. Certification in Regulatory Affairs (e.g., RAC) is a plus.
Work Environment
The office is clean, orderly, properly lighted, and ventilated.
Noise levels are considered low to moderate.
Field conditions vary.
Exposed to various raw materials, including allergens (i.e.
milk, eggs, fish, shellfish, tree nut, peanuts, wheat, soy).
Physical Demands
While performing the duties of this job, the employee is frequently required to bend, crawl, sit, talk, move about, hear and speak.
May be required to work in restricted spaces and/or under difficult lighting and access conditions.
The employee must occasionally lift and/or move up to 10-20 pounds and be able to use appropriate support equipment to lift and move greater amounts.
Must be able to stand for approximately 8 hours.
Must be able to work independently, in a team environment, and drive projects to solution.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Employee is required to use properly use such safety equipment as is appropriate to the work to prevent injury to self or others.
Additional Information
The Salary Range for this position at Lief Labs is $33.00 - $ 40.00 (USD).
Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education.
The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and PTO.
This position is bonus eligible.
Lief is an Equal Opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability.
To request accommodation, contact the Lief Human Resources department.
Lief will consider employment-qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.
Lief uses E-Verify to confirm work eligibility in the United States.
E-Verify compares the information on your Form I-9, Employment Eligibility Verification, to official government records.