What are the responsibilities and job description for the Regulatory Affairs Manager position at Westwood Laboratories?
Regulatory Affairs Manager
Location: Azusa, California
Employer: Westwood Laboratories
About Us:
At Westwood Laboratories, we’re proud of our history — and even more excited about our future. As a trusted contract manufacturer in the health and beauty, OTC, therapeutic drugs, pet care, and personal care industries, we’ve been raising the bar since 1948. With a legacy of FDA-licensed excellence and a culture built on teamwork and innovation, we’re growing — and looking for the right people to grow with us.
About the Role:
We’re looking for a knowledgeable, detail-driven Regulatory Affairs Manager to lead our regulatory compliance programs and ensure that our products meet the highest industry and regulatory standards. You’ll play a key role in managing facility and product registrations, ensuring MoCRA compliance, navigating OTC monographs, and partnering across departments to keep our manufacturing operations inspection-ready and future-focused.
If you’re passionate about regulatory excellence and want to join a company where you’ll have a real voice and impact, this is your chance.
What You’ll Do:
- Lead regulatory compliance activities for OTC drugs, personal care products, and cosmetics under FDA regulations (21 CFR 210/211/330/700).
- Manage and maintain Drug Establishment Registrations and Drug Listings via FDA's eDRLS system.
- Oversee regulatory review and approval of raw materials, formulas, labeling, artwork, and marketing claims.
- Monitor regulatory changes and proactively adapt compliance strategies.
- Guide teams through MoCRA requirements, including product registration, adverse event reporting, and labeling updates.
- Host FDA inspections and third-party audits; lead timely CAPA responses and drive continuous improvement.
- Support R&D, Quality, and Production teams during development, innovation, and change management processes.
- Maintain regulatory files, internal policies, and standard operating procedures (SOPs).
What You Bring:
- Bachelor’s degree in Chemistry, Biology, Regulatory Affairs, or related field (advanced degree preferred).
- 5 years of hands-on regulatory affairs experience in an FDA-regulated environment, with a strong focus on OTC drug regulations.
- Deep knowledge of FDA regulations (21 CFR 210/211/330), OTC monographs, USP/NF standards, labeling regulations, and FDA registration/listing systems.
- Experience managing SPL files, facility registrations, and product listings.
- Strong attention to detail and organizational skills.
- Excellent verbal and written communication skills.
- Proficiency with Microsoft Office and regulatory databases/tools like FDA eDRLS and DailyMed.
Salary Range:
$85,000 - $110,000 per year (based on experience)
Why Westwood Laboratories?
- Be part of an exciting chapter of growth and innovation at a company with a 75 year legacy.
- Work alongside a passionate, collaborative team that truly supports each other.
- Take ownership of meaningful regulatory projects and have a real seat at the table.
- Make an impact in a company that values quality, continuous improvement, and doing things right.
If you’re ready to help shape the future of regulatory excellence at Westwood Laboratories, we would love to meet you.
Apply today and let’s grow together.
Job Type: Full-time
Pay: $85,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Commute:
- Azusa, CA 91702 (Required)
Ability to Relocate:
- Azusa, CA 91702: Relocate before starting work (Required)
Work Location: In person
Salary : $85,000 - $110,000
