Research & Development Regulatory Technician bei Bell International Laboratories, Inc
Bell International Laboratories, Inc · Eagan, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Eagan
Description
Position Summary:
The R&D Regulatory Technician will play a critical role in supporting the Research & Development team with the documentation and compliance aspects of cosmetic and OTC product development. This position is responsible for coordinating regulatory documentation, ensuring formula compliance, verifying ingredient documentation, supporting product claims substantiation, and assisting in the preparation technical files. The ideal candidate will bridge the gap between formulation and regulatory, ensuring all projects meet applicable FDA, INCI, and other regulatory requirements.
Reporting directly to the VP of R&D, this role contributes to bringing safe, effective, and compliant skincare and suncare products from concept to commercialization while ensuring best practices and standards are followed throughout the development process.
Key Responsibilities:
- Document Control & Regulatory File Management
- Maintain and organize all regulatory documentation for R&D projects, including formula worksheets, batch records, ingredient documentation (SDS, COA, TDS, IFRA, allergen statements), and regulatory dossiers.
- Ensure accurate and complete records are created and maintained for internal and external audits.
- Formula & Ingredient Compliance
- Review raw materials and finished product formulations to ensure compliance with applicable FDA, OTC monograph, and other international regulations.
- Verify that all raw materials used in development have up-to-date documentation and certifications to support product safety, claims, and compliance.
- Claims Support & Regulatory Substantiation
- Assist in compiling technical support for product marketing claims (e.g., non-comedogenic, dermatologist tested, reef safe, broad spectrum).
- Create and maintain claim substantiation files, ensuring all supporting data (clinical, analytical, or third-party testing) is properly documented.
- Good Face Project Support
- Act as the regulatory point of contact for the Good Face Project platform, ensuring accurate and timely input of raw material documentation, including SDS, COAs, allergen statements, IFRA certificates, and other required data.
- Maintain and update ingredient profiles within the platform to enable accurate screening of formulations for regulatory compliance (e.g., EU, US, Sephora clean, Credo, etc.).
- Support the R&D team in uploading and managing formulations within the Good Face system to evaluate product compliance across multiple regulatory and “clean beauty” standards.
- Ensure that all data entered into the platform aligns with current FDA guidelines, global cosmetic regulations, and internal best practices.
- Collaborate with formulators to develop checklists and internal workflows that ensure Good Face Project data remains accurate and up to date on an ongoing basis.
- Provide regular support and troubleshooting for the platform and stay current on updates or new features released by Good Face to ensure continued optimization
- Labeling Review
- Assist in reviewing product labels, ingredient lists (INCI), and Drug Facts (for OTC) to ensure accuracy and compliance
- Batch & Technical Documentation Support
- Support R&D Chemists in preparing technical documents for pilot batches, scale-ups, and stability studies.
- Ensure all documentation associated with lab work (batch sheets, formula revisions, testing results) is reviewed and filed according to SOPs.
- Cross-Functional Collaboration
- Collaborate with QA/QC, Project Management, and Production teams to ensure a seamless handoff of compliant formulations and documentation packages as needed
Requirements
Required Skills & Competencies:
- Experience in technical writing and managing product-related documentation
- Excellent organizational skills with strong attention to detail and data accuracy
- Ability to review and interpret SDS, COAs, IFRA certificates, and other regulatory documents
- Strong communication and cross-functional collaboration skills
- Proficiency in Microsoft Office (especially Excel, Word, Outlook)
- Ability to manage multiple projects and shifting priorities in a deadline-driven environment
Required Education & Experience:
- Bachelor’s degree in chemistry, Cosmetic Science, Regulatory Affairs, or a related scientific field
- Experience with R&D documentation, or compliance support role within the cosmetic, OTC, or personal care industry
Preferred Education & Experience:
- 1-2 years of experience with Good Face Project
- Experience in regulatory support for OTC products (e.g., sunscreens, acne treatments, antiperspirants)
- Knowledge of global cosmetic regulations and documentation standards
- Experience in claim substantiation processes and documentation for personal care products
- Working knowledge of FDA requirements for labeling, formula review, and product development practices