Essential Wholesale & Labs is a fast-growing cosmetics manufacturer located in Portland, Oregon. We create premium skin and hair care products available via wholesale to the public or through our custom lab, with all our facilities onsite in the NW industrial district. Our mission is to help beauty companies of all sizes grow and thrive with our sustainable, clean beauty-focus, and accessible products. Our customers sell these stock, custom, or semi-customized products under their brands at places as small as farmer's markets up to international retailers like Sephora and Target.
Regulatory Compliance Specialist
The Regulatory Compliance Specialist monitors the company’s production activities and ensures compliance with applicable regulations and standard operating procedures.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
- Identification, prevention, monitoring and detection, resolution, and advisory accountability.
- Identify risks that EW&L faces and advises on how to avoid or address them.
- Develops strategies to ensure the company’s production activities comply with government regulations.
- Serves as a liaison between regulatory bodies and operating divisions of the company.
- Prepares and submits applications and reports to applicable regulatory agencies.
- Responds to requests for information from regulatory bodies.
- Coordinates with operations, laboratory, quality control, and sales departments regarding product design and development to ensure compliance with regulations.
- Assists with the development of standards for the company’s operating and production procedures.
- Maintains current knowledge of regulations applicable to the company.
- Monitors regulatory affairs and the effect changes will have on company operations.
- Develops and maintains professional relationships in federal, state, and local regulatory agencies.
- Compiles documentation for global product registrations, including maintenance of Product Information Files.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance with regulations.
- Reviews labeling to ensure compliance with domestic and international standards and regulations and consistency with regulatory submissions/approvals.
- Performs other related duties as assigned.
- Supervises Compliance Clerk
Required education and experience:
- BA/BC of Science; preferably in Chemical, Biochemistry or Microbiology
- 1 years’ experience in Regulatory Affairs; cosmetic manufacturing or FDA regulated industry highly preferable.
- Contract Manufacturing Experience Preferred
- Knowledgeable with international regulations and be able to prepare documentation and communicate with international agencies.
- Advanced PC Knowledge i.e., MS Office Suite (Excel, Word, Outlook)
- Extensive knowledge of applicable government regulations
- Ability to inform and educate managers and department heads on regulations and policies that require compliance.
- Excellent written and verbal communication skills
- Excellent analytical and problem-solving skills
Preferred Education and experience:
- Knowledge of cGMP in cosmetic products
- Knowledge of FDA and State regulations for cosmetic and OTC drugs.
- Demonstration of continual education -through membership in recognized organizations, seminars attended, & certifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.
This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.