Quality - Regulatory Affairs Manager
Englewood Lab, Inc.•Totowa, NJ
•$90,000 - $120,000•Onsite
About The Position
The Regulatory Affairs Manager is responsible for leading site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, facility registrations, and cross-functional coordination to ensure full adherence to applicable global regulations. The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related field (Advanced degree preferred).
- Minimum 7 years of regulatory experience in the pharmaceutical, cosmetic, medical device, or other regulated industries.
- Strong working knowledge of FDA regulations (21 CFR Parts 210 & 211).
- Demonstrated experience leading regulatory audits and global regulatory submissions.
- Experience working within global or matrix organizations is preferred.
- Strong leadership, communication, and cross-functional collaboration skills.
- Strong analytical thinking and regulatory risk assessment capabilities.
Responsibilities
- Lead preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits.
- Own the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMFs), and global regulatory submissions.
- Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements.
- Oversee issuance of Raw Material regulatory statements, including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations.
- Lead regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs.
- Direct vendor communication and ensure timely collection and verification of regulatory documentation.
- Oversee regulatory compliance documentation generated through internal and third-party systems.
- Conduct regulatory reviews of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans.
- Lead product and facility registrations and serve as the primary contact for regulatory agency correspondence.
- Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations.
- Oversee regulatory-related SOP development, Change Control, and Quality Management System (QMS) compliance.
- Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance.
- Provide regulatory leadership and guidance to cross-functional teams while supporting global quality initiatives.
- Review OTC Drug Listings and OTC Artwork.
Benefits
- Medical, Dental & Vision Insurance
- Company-paid Life, AD&D and Disability Insurance
- 401(k) with Company Match
- Paid Time Off (PTO)
- Paid Company Holidays
- Special Paid Leave for Personal Events
- Employee Referral Program
- Year-End Gift
- Additional benefits as outlined in the Employee Handbook
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What This Job Offers
Job Type
Full-time
Career Level
Manager
