Regulatory Specialist I

United States·OmahaFull Time Regularmid

Legal & ComplianceRegulatory Specialist

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Quick Summary

Overview

Position Description The Regulatory Specialist provides comprehensive regulatory support for chemists through formula reviews, regulatory interpretation, raw material evaluation,

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Legal & ComplianceRegulatory Specialist

The Regulatory Specialist provides comprehensive regulatory support for chemists through formula reviews, regulatory interpretation, raw material evaluation, and general consultation. Also manages special projects as assigned to support overall strategic business targets with little oversight.

Responsibilities

~1 min read

→Enter, review, and analyze data in the Product Lifecycle Management system in accordance with established processes and procedures.
→Complete detailed raw material, formula, and regulation reviews to support product development and customer service.
→Perform detailed reviews of digital artwork files for primary and secondary packaging to ensure compliance with applicable regulations and customer-specific requirements. [Extensive training provided. No prior experience necessary.]
→Prepare regulatory documentation as needed for product registration purposes. Documents include but are not limited to Good Manufacturing Statements, Certificates of Free Sale, and parts of Sally Beauty Regulatory Packets.
→Compile pre-existing regulatory documentation per customer request or as needed for EU Product Information Files (PIF).
→Submit product information to UL WERCSmart® Manufacturer Portal for product registration with specific retailers.
→Communicate with suppliers of raw materials to request regulatory information.
→Evaluate alternate chemical suppliers.
→Enter and review formulas in the computer system.
→Maintain accurate files of regulatory documentation.
→Maintain a good attendance record.

Minimum of 1-3 years of experience in regulatory compliance in an FDA-regulated industry such as cosmetics, drugs, medical devices, or food. Experience with personal care, pet care, or household and industrial products is preferred.
Functions with moderate supervision.

Minimum of 3-7 years of experience in regulatory compliance of FDA-regulated industries such as cosmetics, drugs, medical devices, or food. Experience with personal care, pet care or household and industrial products is preferred.
Function autonomously on typical projects and with little supervision on complex projects.
Provide technical/regulatory expertise and support to Marketing and Innovation during development or review of new and existing products.
Develop and maintain SOPs.
Participate in project team meetings, providing project updates when requested targeting on-time completion.
Evaluate alternate chemical suppliers from a regulatory perspective.
Manage raw material maintenance, including setup and validation of new and existing raw materials to fully support R&D and Regulatory activities.
Provide comprehensive regulatory support for chemists through formulation reviews, regulatory interpretation, raw material evaluation, and general consultation.
Manage special projects as assigned to support overall strategic business targets with little oversight.

Perform other duties as assigned.

Bachelor’s degree in science (Chemistry, Engineering, or Biology Preferred).

Advanced attention to detail.
Strong communication skills.
Capability to maintain focus and high productivity while seated at a computer for long periods of time.
Ability to read, write, and speak English competently.
Ability to maintain regular, reliable, and predictable attendance.
Ability to work onsite.

Nice to Have

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Experience working with legal documents.
Knowledge of chemistry and scientific methods.
Basic lab skills.

Primarily office environment – climate-controlled.
Periodic visits to:
- Warehouse environment – some temperature extremes, dust, and noise.
- Manufacturing environment – some temperature extremes, dust, noise, and wet conditions.
Travel expectations are up to 10% annually.

The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria considered necessary to perform the job successfully. Cohere Beauty recognizes that an individual with a disability may require accommodation to enable him/her to successfully perform a job function. Consideration will be given to reasonable accommodation.

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