Global Regulatory Affairs Lead – GMP & Submissions

Englewood Lab, Inc.; Totowa (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Life/AD&D Insurance

401(k) with Match

Paid Time Off

Paid Holidays

Personal Leave

Employee Referral Program

Year-End Gift

Employee Handbook access

Job summary

Englewood Lab, Inc. is seeking a Regulatory Affairs Manager to lead regulatory operations at our Totowa, NJ site, ensuring alignment with global regulatory strategy and quality standards.

You will oversee regulatory compliance, submissions, and facility registrations while coordinating cross-functionally to support audits and regulatory programs. Strong FDA knowledge and leadership are essential.

Qualifications

• Minimum 7 years of regulatory experience in 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, Drug Master Files, and global regulatory submissions.
• Review and approve compliance documentation for domestic and international requirements.
• Oversee issuance of regulatory statements including Origin, REACH, Allergen, and other global declarations.
• Lead regulatory submissions related to Organic, Gluten-Free, MoCRA, CARES Act reporting, and other programs.
• Direct vendor communication and ensure timely collection and verification of regulatory documentation.
• Oversee regulatory documentation generated through internal and third-party systems.
• Conduct regulatory reviews of formulas and ingredients to ensure compliance across markets; identify regulatory risks and mitigation plans.
• Lead product and facility registrations and serve as the primary contact for regulatory agency correspondence.
• Ensure ongoing compliance with FDA, EPA, OSHA, Health Canada, ISO, EU, China CSAR, Japan and other global regulations.
• Oversee regulatory-related SOP development, Change Control, and QMS compliance.
• Monitor evolving global regulatory requirements and implement necessary updates.
• Provide regulatory leadership and guidance to cross-functional teams and support global quality initiatives.
• Review OTC Drug Listings and OTC Artwork.

Skills

Leadership

Communication

Cross-functional collaboration

Regulatory submissions

Regulatory audits

Regulatory risk assessment

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Advanced degree preferred

Job description

Englewood Lab, Inc. is seeking a Regulatory Affairs Manager to lead regulatory operations at our Totowa, NJ site, ensuring alignment with global regulatory strategy and quality standards.

You will oversee regulatory compliance, submissions, and facility registrations while coordinating cross-functionally to support audits and regulatory programs. Strong FDA knowledge and leadership are essential.