Quality - Regulatory Affairs Associate

Englewood Lab, Inc.•Totowa, NJ

1d•$58,000 - $70,000•Onsite

About The Position

The Regulatory Affairs Associate supports the Manager of Regulatory Affairs with inspections, audits, regulatory compliance, and the creation and maintenance of product and drug documentation and regulatory statements. The role works with QA/QC personnel, customers, production supervision, warehouse, engineering, operations, and regulatory agencies. This is a full-time, exempt, onsite position based at Englewood Lab, Inc. in Totowa, New Jersey. The standard schedule is Monday through Friday, with additional hours potentially required for audits, regulatory submissions, or deadline-driven initiatives. Work is primarily in an office, with regular visits to manufacturing, warehouse, and laboratory areas. Compensation is $58,000–$70,000 per year, and the position is eligible for the company’s discretionary bonus program.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related profession.
Experience with drug and cosmetic regulatory processes.
Familiarity with FDA requirements under 21 CFR Parts 210 and 211.
At least 2 years of industry or related experience in cosmetics.
Computer literacy and effective communication skills.

Nice To Haves

Previous regulatory, inspection, auditing, or manufacturing experience.
Data analysis skills.

Responsibilities

Assist the Manager of Regulatory Affairs during cGMP, environmental, and regulatory audits.
Create and collate Product Master Files (dossiers) and Drug Master Files (DMFs), with assistance from the Head of R&D or designee.
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 for local and international submissions as needed.
Generate raw material regulatory statements, including origin, cruelty-free, heavy metal, impurity, food allergen, fragrance allergen, nitrosamine-free, 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 SOPs and applicable regulatory and trade organization requirements, including FDA, EPA, OSHA, ISO 13485:2003, COSMOS/ECOCERT, and other applicable requirements.
Manage 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 with periodic quality reviews, regulatory updates, and annual GMP training.
Maintain familiarity with SOP generation, specification controls, and the Change Control program.
Maintain familiarity with Quality Management Systems (QMS) in compliance with 21 CFR Parts 210 and 211 and with changing global regulatory requirements.
Perform compliance assessments and generate compliance reports for new formulas under development as needed to support product launches.
Generate, review, and maintain reports related to COSMOS Natural, COSMOS Organic, and NOP requirements for ingredients and products.
Perform additional duties or assignments as directed by the Manager of Regulatory Affairs or manager.