Global Regulatory Affairs Manager — Onsite

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D Insurance

Disability Insurance

401(k) Match

Paid Time Off

Paid Holidays

Special Leave

Referral Program

Job summary

Englewood Lab, Inc. is seeking a Regulatory Affairs Manager to lead site regulatory operations in Totowa, NJ, onsite.

You will align with global regulatory strategy and corporate quality standards, ensuring compliance, submissions, and registrations while coordinating with site operations and global quality leadership. The role oversees regulatory documentation, audits, and regulatory program execution across multiple global markets, including FDA, EPA, OSHA, and Health Canada, with a focus on

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum 7 years of regulatory experience in pharma, cosmetics, medical devices or other regulated industries.
• Strong leadership and cross-functional collaboration capabilities.

Responsibilities

• Lead regulatory inspections, cGMP audits, and environmental audits coordination.
• Develop, review and maintain Product Master Files (DMFs, dossiers) and global submissions.
• Review and approve compliance documentation for domestic and international requirements.

Skills

Leadership

Communication

Cross-functional collaboration

Analytical thinking

Regulatory risk assessment

Education

Bachelor’s degree in Life Sciences/Engineering

Job description

Englewood Lab, Inc. is seeking a Regulatory Affairs Manager to lead site regulatory operations in Totowa, NJ, onsite.

You will align with global regulatory strategy and corporate quality standards, ensuring compliance, submissions, and registrations while coordinating with site operations and global quality leadership. The role oversees regulatory documentation, audits, and regulatory program execution across multiple global markets, including FDA, EPA, OSHA, and Health Canada, with a focus on