Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to join our team. This role involves reviewing and maintaining supplier documentation for all raw materials, creating and managing product specifications, and ensuring compliance with applicable regulations. The ideal candidate will have a strong experience in regulatory affairs within the dietary supplement or nutraceutical industry.

Responsibilities

• Review and maintain supplier documentation for all raw materials, including declarations and compliance statements.
• Create, approve, and maintain finished product and raw material specifications, ensuring alignment with labels and supplier documentation.
• Review and approve dietary supplement product labels and marketing materials for compliance with FDA/FTC regulations.
• Lead and facilitate third-party certifications by coordinating applications, collecting evidence, and managing renewals.
• Ensure on-time submission and confirm that finished products and raw materials meet program requirements.
• Collaborate with R&D, Quality, Operations, Purchasing, Sales/Marketing, Graphics, and Customer Service to maintain compliance.
• Lead regulatory impact assessments for formula, label, or packaging changes, and coordinate notifications as needed.
• Assist in the international registration process through ingredient and claims vetting against local standards.
• Monitor regulatory updates and enforcement trends and provide guidance to stakeholders.

Essential Skills

• 5-7 years of regulatory experience in the dietary supplement or nutraceutical industry.
• Proficiency in DSHEA, 21 CFR Part 101, 21 CFR Part 111, and 21 CFR Part 117.
• Bachelor's degree in chemistry, biology, nutrition, or a related science field.
• Strong understanding of FDA compliance and regulatory affairs.
• Accuracy in technical documentation.

Work Environment

The work environment includes cubicles with high walls and standing desks. After 3-6 months of training, there is potential for one work-from-home day per week. The role requires cross-functional collaboration with multiple teams and customer interfacing.

This is a Permanent position based out of Edison, NJ.

The pay range for this position is $70000.00 - $80000.00/yr.

Health & Insurance Programs • Medical & Pharmacy: Covers 91% of claims costs. • Dental & Vision Insurance included. • Health Savings Account (HSA) available. Life & Disability Coverage • Basic & Supplemental Life Insurance. • Short-Term & Long-Term Disability options. • Voluntary coverages: Accident, Cancer, Critical Illness, Hospital Indemnity. Employee Support Services • Employee Assistance Program (EAP) for mental health and life planning. • Telehealth services for convenient remote consultations. Leave & Wellness Policies • Absence benefits for short-term leaves and disabilities. Key Highlights • High medical coverage percentage. • Robust insurance options. • Supportive workplace environment. • Opportunities for learning and growth.

This is a fully onsite position in Edison,NJ.

This position is anticipated to close on Jan 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $70,000 - $80,000