Global Regulatory Affairs Specialist – Submissions & Compliance

PakLab; Chino (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

You will prepare registrations and dossiers, review labeling and packaging, maintain regulatory documentation, and collaborate with R&D, Quality, Operations, and Supply Chain to ensure all products meet regulatory requirements. This role also monitors regulatory changes, supports international submissions, and advises teams on compliant claims and packaging.

Qualifications

• Bachelor's degree or higher in Regulatory Affairs, Life Sciences, Chemistry, Biology, or related field.
• 3–5 years of experience in regulatory affairs, compliance, or quality assurance in manufacturing or consumer product industries.
• Experience with international regulatory submissions and product registrations preferred.
• Background in cosmetics, pharmaceuticals, dietary supplements, or consumer packaged goods strongly preferred.

Responsibilities

• Prepare, review, and submit product registrations, notifications, and dossiers to regulatory authorities and customers.
• Ensure packaging, labeling, and product claims comply with FDA, FTC, EU, and other applicable regulations.
• Maintain regulatory databases and documentation, ensuring accuracy and timely updates.
• Support international product registrations and compliance with country-specific requirements.
• Monitor and interpret changes in regulations and communicate impacts to internal stakeholders.

Skills

Regulatory knowledge

Attention to detail

Project management

Written and verbal communication

Microsoft Office

Independent work and cross-department

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, or related field

Job description

You will prepare registrations and dossiers, review labeling and packaging, maintain regulatory documentation, and collaborate with R&D, Quality, Operations, and Supply Chain to ensure all products meet regulatory requirements. This role also monitors regulatory changes, supports international submissions, and advises teams on compliant claims and packaging.