Regulatory Affairs Specialist Jobs

About The Position

Requirements

• Bachelor's degree in Regulatory Affairs, Food Science, Biology, Chemistry, Life Sciences, or related field preferred; equivalent experience may be considered.
• 3–5 years of regulatory, quality, or compliance experience in a regulated manufacturing environment.
• Knowledge of FDA dietary supplement regulations, DSHEA, and 21 CFR Part 111.
• Strong technical writing, organization, analytical, and communication skills.
• Proficiency with Microsoft Office and electronic document or quality management systems.

Nice To Haves

• Experience with dietary supplement labeling and claims preferred.
• Experience with NSF, USP, Organic, Non-GMO, Kosher, or Halal certifications is a plus.

Responsibilities

• Ensure compliance with FDA, DSHEA, and 21 CFR Part 111 cGMP requirements.
• Review product labels, Supplement Facts panels, ingredients, and marketing claims.
• Evaluate regulatory risks for new products, formulations, and ingredients.
• Maintain regulatory SOPs, product specifications, SDS files, and controlled documentation.
• Support Document Control and Change Control activities.
• Complete customer regulatory questionnaires and documentation requests.
• Support regulatory, customer, and third-party certification audits.
• Assist with registrations, licenses, corrective actions, and regulatory inspections.
• Provide regulatory guidance to R&D, Quality, Marketing, and other departments.

Benefits

• Flexible Spending Account & Health Savings Account options
• Voluntary Life Insurance
• Short-Term & Long-Term Disability
• 401(k) Plan with up to 6% Match
• Paid Time Off
• Paid Holidays (8 holidays)
• Quarterly Vitamin Allowance (up to $150)
• Employee Wellness Program
• Performance based spot bonuses