What are the responsibilities and job description for the Regulatory Affairs Specialist position at HCT by kdc/one?
Basic Function
The Regulatory Affairs Specialist will support the Regulatory Department in regulatory compliance-related documentation. They will work closely with the Regulatory Affairs Manager and Coordinator to communicate any issues. The specialist will work with internal departments to ensure that all regulatory compliances are met during product development. They will also assist in preparing regulatory filings and applications to authorities, ensuring accuracy and completeness. They play a key role in maintaining and updating regulatory files and databases.
Job Responsibilities - Other duties may be assigned
- Respond to supervisors and project managers inquiries, issues, requests in a quick and efficient manner
- Prioritize and handle multiple projects concurrently
- Ensure confidentiality when dealing with regulatory documents
- Stay informed of regulatory changes and industry trends to provide timely updates and recommendations to Regulatory Department
- Respond to inquiries and requests in a quick and efficient manner
- Responsible for collecting, reviewing and releasing various ‘regulatory’ documents such as Certificates of Free Sale & GMP Certificates for International Product Registration and other generic ‘statements’ as needed.
- Manage and handle ‘Leaping Bunny’/Animal Testing requests
- Help maintain Finished Goods SDS (Safety Data Sheets)
- Assist in obtaining necessary documents
- Create Net Quantity Worksheets for the factories and determine fill weights for label claims
- Review and release Net Contents (DNC) forms and related samples (along with Quality/Todor)
- Review customer artwork and label copy for accuracy to domestic and international compliance
- Review formulas for Claims and issue Statements
- Review and help write Marketing Sheets with Product Development team and Project Managers
- Manage and maintain MOCRA related tasks and questions on both Customer side (FEI number, FDA Cosmetics Direct Portal verification, Product Category ,…) and CMO side (Product Name, Brand Responsible Person and Company address, Product Category,…)
- Collect and maintain CMOs GMP and ‘other’ certificates (ISO,….)
- Participating in the Project Managers training as needed and related to her tasks and responsibilities
- Manage subordinate staff (Regulatory Affairs Coordinator) in the day-to-day performance of their job
- Experience managing and navigating projects utilizing Coptis & Wrike
- Other duties as requested
Qualifications / Education and/or Experience:
- BA/BS in Science (or relevant Regulatory certification)
- 1 to 3 Years of related work coordination work experience
- 3 years cosmetic industry experience preferred
- Strong attention to detail
- Self-starter
- Ability to adapt to changing priorities and multi-task
- Ability to determine priorities and re-prioritize as needed
- Ability to meet deadlines
- Positive and Inspiring team player with a passion for one’s job
- Motivated, proactively anticipates departmental needs
- Computer Literacy, MS Office, Adobe Illustrator
- Basic knowledge of Microsoft Word, Excel, PowerPoint
- Coptis & Wrike experience preferred