Quality - Regulatory Affairs Associate

Location: Totowa, New Jersey (Onsite)
Employment Type: Full-Time / Exempt
Department: Quality / Regulatory
Reports To: Manager of Regulatory Affairs

The Regulatory Affairs Associate will assist the Manager of Regulatory Affairs with inspections and audits, ensuring compliance.

The Regulatory Affairs Associate will also create and maintain essential product and drug documentation and regulatory statements. This position will have contact with all areas of QA/QC personnel, customers, production supervision, warehouse, engineering and operational personnel, and regulatory agencies.

The Regulatory Affairs Associate is responsible for supporting the company’s business activities through a variety of tasks, including:

• Assist the Manager of Regulatory Affairs during cGMP, environmental, and regulatory audits.
• With the assistance of the Head of R&D or designee, create and collate Product Master Files (dossiers) and Drug Master Files (DMFs).
• Generate and review Product CoCs, CoAs, CoMs, BSE documents, CMR documents, Raw Material Certificates of Analysis, Safety Data Sheets, technical documents, and raw material composition breakdowns, as may be required for local and international submissions.
• Generate Raw Material Regulatory Statements, including Origin Statements, Cruelty-Free Statements, Heavy Metal Statements, Impurity Statements, Food Allergen Statements, Fragrance Allergen Statements, Nitrosamine-Free Statements, PFAS, Benzene, and DEG/EG Statements.
• Review customer “No-No Lists,” Special Store Prohibited Lists, Prop 65 requirements, REACH-compliant statements, certified organic ingredients, global and regional compliance reports and statements, EU/China-compliant statements, and requirements for other global jurisdictions, as applicable.
• Coordinate investigations, including audit findings, correspondence related to regulatory audits, and registration of products and facilities with regulatory agencies.
• Ensure compliance with all SOPs and other regulatory and trade organizational requirements, including FDA, EPA, OSHA, ISO 13485:2003, COSMOS/ECOCERT, and other applicable requirements.
• Be responsible for facility registrations, renewals, and document submissions to regulatory agencies, including drug and cosmetic listings, under the direct supervision of the Head of Quality/Regulatory.
• Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training.
• Maintain familiarity with the SOP generation process, specification controls, and Change Control program.
• Maintain familiarity with Quality Management Systems (QMS) in compliance with 21 CFR Parts 210 and 211.
• Maintain familiarity with changing global regulatory requirements.
• Perform compliance assessments and generate compliance reports for new formulas undergoing development, as needed to support new product launches.
• Generate, review, and maintain reports related to COSMOS Natural, COSMOS Organic, and NOP requirements for ingredients and products.
• Perform any additional duties or assignments as directed by the Manager of Regulatory Affairs.
• Perform other duties as assigned by the manager.

• Minimum of a bachelor’s degree in Life Sciences, Engineering, or a related profession.
• Experience with drug and cosmetic regulatory processes is required.
• Familiarity with FDA requirements under 21 CFR Parts 210 and 211 is required.
• At least 2 years of industry or related experience in cosmetics is required.
• Previous regulatory, inspection, auditing, or manufacturing experience is a plus.
• Data analysis skills are a plus.
• Computer literacy and effective communication skills.

• This is an onsite position based at Englewood Lab, Inc., 20 Campus Road, Totowa, New Jersey.
• The standard schedule is Monday through Friday, full-time.
• Additional hours may be required to support audits, regulatory submissions, or deadline-driven initiatives.

• Work is performed in an office environment, with regular visits to the manufacturing floor, warehouse, and laboratory areas to support audits, inspections, and documentation.
• Must…