Regulatory Document Specialist
La Verne, California
Permanent
$25.00 - $30.00 per Hour
Regulatory Documentation Specialist
On-site: Pomona
We are seeking a Regulatory Documentation Specialist to manage all aspects of the technical documentation process, ensuring compliance with FDA regulatory guidelines and internal standards. This role is pivotal in maintaining accurate, cGMP-compliant documentation, supporting sales efforts, and liaising with vendors/original manufacturers.
Key Responsibilities
Develop and maintain FDA regulatory documentation, including internal product specifications and Certificates of Analysis.
Support the sales team by managing technical questionnaires and vendor-related documentation.
Collect, update, and interpret technical documentation in line with cGMP requirements.
Proofread documents with exceptional accuracy to ensure compliance and quality.
Conduct research and provide detailed insights to meet technical and regulatory standards.
Provide customer service support as needed.
Qualifications
Required:
Bachelor’s degree in a science-related field OR 3 years of direct experience supporting FDA documentation.
Strong understanding of FDA regulatory guidelines and cGMP requirements.
Proficiency in MS Office applications, especially Word, Excel, and PDF tools.
Exceptional attention to detail, accuracy, and organizational skills.
Strong verbal and written communication abilities.
Preferred:
Experience in technical writing or proofreading with a high degree of precision.
Demonstrated ability to manage multiple priorities in a fast-paced environment.
Why Join Us?
Work with a dynamic team committed to excellence in product quality and customer service.
Opportunity to contribute to a critical aspect of regulatory compliance and operational efficiency.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
Regulatory Document Specialist
LHH
1 days ago
$25.00 - $30.00 per Hour
Permanent
La Verne, California
Regulatory Documentation Specialist
On-site: Pomona
We are seeking a Regulatory Documentation Specialist to manage all aspects of the technical documentation process, ensuring compliance with FDA regulatory guidelines and internal standards. This role is pivotal in maintaining accurate, cGMP-compliant documentation, supporting sales efforts, and liaising with vendors/original manufacturers.
Key Responsibilities
Develop and maintain FDA regulatory documentation, including internal product specifications and Certificates of Analysis.
Support the sales team by managing technical questionnaires and vendor-related documentation.
Collect, update, and interpret technical documentation in line with cGMP requirements.
Proofread documents with exceptional accuracy to ensure compliance and quality.
Conduct research and provide detailed insights to meet technical and regulatory standards.
Provide customer service support as needed.
Qualifications
Required:
Bachelor’s degree in a science-related field OR 3 years of direct experience supporting FDA documentation.
Strong understanding of FDA regulatory guidelines and cGMP requirements.
Proficiency in MS Office applications, especially Word, Excel, and PDF tools.
Exceptional attention to detail, accuracy, and organizational skills.
Strong verbal and written communication abilities.
Preferred:
Experience in technical writing or proofreading with a high degree of precision.
Demonstrated ability to manage multiple priorities in a fast-paced environment.
Why Join Us?
Work with a dynamic team committed to excellence in product quality and customer service.
Opportunity to contribute to a critical aspect of regulatory compliance and operational efficiency.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance