Quality - Regulatory Affairs Manager

Englewood Lab, Inc.; Paterson (NJ); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Communication

Cross-functional collaboration

Analytical thinking

Regulatory risk assessment

Ausbildung

Bachelor’s degree in Life Sciences/Engineering

Jobbeschreibung

Regulatory Affairs Manager

Location: Totowa, NJ (Onsite)
Employment Type: Full-Time | Exempt
Department: Regulatory Affairs
Reports To: Global Chief of Quality (GCQO)

Position Summary

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.

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Key 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.

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Qualifications

- 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.

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Work Schedule

- Onsite position based in Totowa, New Jersey.
- Monday through Friday, Full-Time.
- Additional hours may be required to support audits, inspections, regulatory submissions, and business needs.

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Compensation

$90,000 - $120,000 annually

Actual compensation will be determined based on experience, qualifications, skills, and internal equity. This position is also eligible for the company's discretionary bonus program.

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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
- Additional benefits as outlined in the Employee Handbook

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Equal Opportunity Employer

Englewood Lab, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, pregnancy, veteran status, or any other characteristic protected by applicable federal, state, or local law. Englewood Lab provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law.