Regulatory Affairs Manager Job in Totowa, NJ | Englewood Lab
Overview
You will own site regulatory operations for a full-service contract manufacturer, ensuring alignment with global quality strategy. You'll lead FDA (21 CFR Parts 210 & 211) compliance, regulatory submissions, and facility registrations across markets including EU, China CSAR, and Health Canada. Working with the Global Chief of Quality, you'll direct audits and cross-functional teams to keep products compliant from formula to shelf. This role stands out for its end-to-end ownership of regulatory programs like MoCRA and CARES Act reporting, and a direct line to global leadership.
What You'll Do10
- 1Lead preparation and response for regulatory inspections, cGMP audits, and environmental audits, coordinating with cross-functional teams to close findings.
- 2Own the development and maintenance of Product Master Files (Dossiers), DMFs, and global regulatory submissions for new and existing products.
- 3Review and approve compliance documentation including CoCs, CoAs, and SDS for domestic and international requirements.
- 4Oversee issuance of Raw Material statements such as REACH, Allergen, and Nitrosamine-Free declarations for global markets.
- 5Drive regulatory submissions for USDA Organic (Ecocert), Gluten-Free, MoCRA, and CARES Act reporting programs.
- 6Direct vendor communication to collect and verify regulatory documentation, ensuring accuracy and timeliness.
- 7Conduct regulatory reviews of formulas and ingredients, identifying risks and implementing mitigation plans for target markets.
- 8Maintain product and facility registrations, serving as primary contact for agency correspondence including FDA and EPA.
- 9Ensure compliance with FDA (21 CFR Parts 210/211/820), OSHA, ISO, EU, and China CSAR regulations.
- 10Review OTC Drug Listings and artwork, ensuring accuracy for regulatory submissions.
Requirements7
- 1Bachelor's degree in Life Sciences, Engineering, or related field (advanced degree preferred).
- 27+ years in regulatory affairs within pharmaceutical, cosmetic, or medical device industries.
- 3Strong working knowledge of FDA regulations (21 CFR Parts 210 & 211).
- 4Proven experience leading FDA audits and global regulatory submissions.
- 5Experience in global or matrix organizations is preferred.
- 6Strong leadership and cross-functional collaboration skills.
- 7Analytical thinking and regulatory risk assessment capabilities.
Salary Insight
$90 - $120k per year
Location
Required Skills
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