Regulatory Affairs Specialist — Cosmetics & FDA Compliance

Englewood Lab; Totowa (NJ); On-site; USD 58,000 - 70,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Company-paid Life, AD&D, and Disabilty

401(k) Retirement Plan with Employer M

PTO and Company-Paid Holidays

Year-End Gift

Employee Referral Program

Additional benefits per handbook

Job summary

Englewood Lab is seeking a Regulatory Affairs Associate in Totowa, NJ, onsite. The role supports the Manager of Regulatory Affairs with inspections, audits, and documentation to ensure compliance across product lines.

Responsibilities include filing Product Master Files, Drug Master Files, and regulatory statements, coordinating global submissions, and maintaining SOPs and QMS per 21 CFR standards. Strong regulatory knowledge is essential.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Experience with drug and cosmetic regulatory processes.
• Familiarity with FDA 21 CFR Parts 210 and 211.
• At least 2 years of industry experience in cosmetics.
• Data analysis skills are a plus.
• Computer literacy and effective communication skills.

Responsibilities

• Support audits and inspections during cGMP, environmental, and regulatory reviews.
• Assist in preparing Product Master Files and Drug Master Files.
• Generate and review regulatory documents (CoCs, CoAs, CoMs, and SDS).
• Prepare raw material regulatory statements (Origin, Heavy Metals, Allergens).
• Review regulatory lists and compliance statements for global submissions.
• Coordinate investigations and regulatory submissions with agencies.
• Maintain SOPs and QMS documentation aligned with 21 CFR Parts 210/211.
• Support GMP training and periodic quality reviews.

Skills

Regulatory knowledge

Audit support

Documentation

Education

Bachelor's degree in Life Sciences or related field

2+ years cosmetics regulatory experience

Job description

Englewood Lab is seeking a Regulatory Affairs Associate in Totowa, NJ, onsite. The role supports the Manager of Regulatory Affairs with inspections, audits, and documentation to ensure compliance across product lines.

Responsibilities include filing Product Master Files, Drug Master Files, and regulatory statements, coordinating global submissions, and maintaining SOPs and QMS per 21 CFR standards. Strong regulatory knowledge is essential.