Regulatory Affairs Specialist

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

The Regulatory Affairs Specialist is responsible for supporting PakLab’s compliance with federal, state, and international regulations for product development, manufacturing, labeling, and distribution. This role ensures product registrations, submissions, and documentation are accurate and up to date, while monitoring regulatory changes that impact the business. The Regulatory Affairs Specialist collaborates with cross-functional teams including Quality, R&D, Operations, and Supply Chain to ensure all products meet applicable regulatory and customer requirements.

Essential Duties and 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.
• Review and approve raw material and finished product specifications for regulatory compliance.
• Assist with responding to regulatory authority inquiries, audits, and inspections.
• Collaborate with R&D and Marketing to review formulas, product claims, and artwork for compliance.
• Prepare and maintain Safety Data Sheets (SDS), technical files, and product information files (PIFs).
• Participate in cross-functional project teams to ensure regulatory considerations are addressed during product development.
• Support training initiatives for employees on regulatory requirements and labeling compliance.
• Perform other duties as assigned.

Required Skills and Abilities

• Strong knowledge of FDA, FTC, EU, and other global regulatory requirements for cosmetics, OTC drugs, dietary supplements, or consumer products.
• Excellent attention to detail and documentation accuracy.
• Strong organizational, project management, and recordkeeping skills.
• Ability to analyze regulatory requirements and apply them to product development and labeling.
• Effective written and verbal communication skills.
• Proficiency in Microsoft Office and familiarity with regulatory submission systems.
• Ability to work independently and collaborate across departments.

Education and Experience Requirements

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

Physical Demands

• Prolonged periods of sitting at a desk and working on a computer.
• Ability to lift up to 15 pounds occasionally.

Working Conditions

• Work is performed in production, laboratory, and office environments.
• Exposure to varying noise levels, chemicals, and temperature fluctuations may occur.
• Must follow all safety, quality, and regulatory compliance procedures.

Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, disability, medical condition, genetic information, marital status, military or veteran status, or any other protected characteristic.