Full-Time
Quality Regulatory Affairs Manager
Englewood Lab
Compensation Overview
$90k - $120k/yr
+ Discretionary bonus
Totowa, NJ, USA
In Person
Bachelor's
Category
 Legal & Compliance (1) |
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Requirements
- A Bachelor's degree in Life Sciences, Engineering, or a related field is required.
- A minimum of 7 years of regulatory experience in the pharmaceutical, cosmetic, medical device, or other regulated industries is required.
- Strong working knowledge of Food and Drug Administration regulations, including 21 Code of Federal Regulations Parts 210 and 211, is required.
- Demonstrated experience leading regulatory audits and global regulatory submissions is required.
- Strong leadership, communication, and cross-functional collaboration skills are required.
- Strong analytical thinking and regulatory risk assessment capabilities are required.
Responsibilities
- Lead preparation, coordination, and response activities for regulatory inspections, current Good Manufacturing Practice 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, including Certificates of Conformance, Certificates of Analysis, Certificates of Manufacture, bovine spongiform encephalopathy documentation, carcinogenic, mutagenic, or reprotoxic documentation, safety data sheets, and raw material documentation, for domestic and international requirements.
- Oversee issuance of raw material regulatory statements, including origin, Registration, Evaluation, Authorisation and Restriction of Chemicals, allergen, nitrosamine-free, European Union and China compliance, and other global declarations.
- Lead regulatory submissions related to Organic, Gluten-Free, Modernization of Cosmetics Regulation Act, Consumer Access to Reproductive Equity 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 Food and Drug Administration, Environmental Protection Agency, Occupational Safety and Health Administration, Health Canada, International Organization for Standardization, European Union, China CSAR, Japan, and other applicable global regulations.
- Oversee regulatory-related standard operating procedure development, Change Control, and Quality Management System 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 over-the-counter drug listings and over-the-counter artwork.
Desired Qualifications
- An advanced degree is preferred.
- Experience working within global or matrix organizations is preferred.