Quality - Regulatory Affairs Manager
About The Position
The Regulatory Affairs Manager leads site regulatory operations in alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, facility registrations, and cross-functional coordination to ensure adherence to applicable global regulations. The manager serves as the primary regulatory lead for operational execution at the site and communicates between site operations and global quality leadership. The position is based onsite in Totowa, New Jersey, and is full-time, Monday through Friday. Additional hours may be required to support audits, inspections, regulatory submissions, and business needs. The annual compensation range is $90,000–$120,000, based on experience, qualifications, skills, and internal equity; the role is also eligible for the company’s discretionary bonus program.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- At least 7 years of regulatory experience in the pharmaceutical, cosmetic, medical device, or another regulated industry.
- Strong working knowledge of FDA regulations, particularly 21 CFR Parts 210 and 211.
- Demonstrated experience leading regulatory audits and global regulatory submissions.
- Strong leadership, communication, and cross-functional collaboration skills.
- Strong analytical thinking and regulatory risk assessment capabilities.
Nice To Haves
- Advanced degree preferred.
- Experience working within global or matrix organizations preferred.
Responsibilities
- Lead preparation, coordination, and responses for regulatory inspections, cGMP audits, and environmental audits.
- Develop, review, and maintain Product Master Files (Dossiers), Drug Master Files (DMFs), and global regulatory submissions.
- Review and approve compliance documentation, including CoCs, CoAs, CoMs, BSE, CMR, SDS, and raw material documentation, 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 communications and ensure timely collection and verification of regulatory documentation.
- Oversee regulatory compliance documentation generated through internal and third-party systems.
- Review formulas and ingredients for compliance in intended markets, 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 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, and 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.
- Additional benefits as outlined in the Employee Handbook.
- Eligible for the company’s discretionary bonus program.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
