Regulatory Affairs Specialist

Now Hiring: Regulatory Affairs Associate – Quality & Compliance Team

A leading manufacturer in the life sciences industry is seeking a detail-oriented Regulatory Affairs Associate to join its Quality and Regulatory department. This full-time role is ideal for professionals with a background in compliance and documentation who are eager to support global regulatory submissions and quality processes in a fast-paced environment.

Position Overview:

The Regulatory Affairs Associate supports the preparation, maintenance, and submission of regulatory documentation in alignment with domestic and international standards. This role collaborates closely with Regulatory Affairs, Quality, and R&D teams to ensure compliance with FDA, EPA, ISO, and other global regulatory bodies.

Key Responsibilities:

• Support internal and external audits, including cGMP, environmental, and regulatory inspections
• Collaborate with R&D to compile and maintain product master files and Drug Master Files (DMFs)
• Prepare and review regulatory documents such as CoCs, CoAs, CoMs, SDSs, and raw material data
• Draft regulatory statements on Country of Origin, Heavy Metals, Allergen profiles, Nitrosamine content, and more
• Evaluate and respond to customer-specific compliance requirements, including Prop 65, REACH, COSMOS/ECOCERT, and international standards (EU, China, etc.)
• Coordinate documentation for facility registrations and regulatory correspondences
• Maintain compliance with SOPs and applicable regulations (FDA, EPA, OSHA, ISO 13485, etc.)
• Support regulatory submissions, including Drug and Cosmetic Listings and facility renewals
• Assist in GMP training and periodic quality reviews
• Maintain documentation for organic and natural certifications (COSMOS, NOP)
• Stay current with evolving global regulatory trends and industry best practices

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline
• Minimum 2 years of regulatory or quality experience in cosmetics, medical devices, food, or pharmaceuticals
• Working knowledge of FDA regulations (21 CFR Parts 210, 211, 820)
• Familiarity with ISO 13485 and international compliance standards
• Strong documentation and submission skills
• Excellent communication, analytical, and organizational abilities
• Proficient in Microsoft Office and related software tools
• Ability to lift and carry 10–15 lbs when needed

Compensation & Benefits:

• Annual Salary Range: $55,500 – $59,000 (based on experience)
• Medical, Dental, and Vision Insurance
• Company-paid Life Insurance
• 401(k) Plan with Company Match
• Paid Time Off (PTO)

This is a great opportunity to grow your career in regulatory affairs within a collaborative and quality-driven organization. Apply today to be a part of a company that values excellence and regulatory integrity.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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