Regulatory Affairs Specialist (FDA-Regulated)

Actalent; Omaha (NE); On-site; USD 33,000 - 37,000; Full time

Job summary

Actalent is seeking a Regulatory Specialist to provide comprehensive regulatory support across product development, quality, and compliance. You will review formulas, materials, and labeling to ensure regulatory conformity for domestic and international markets, while collaborating with chemists, marketing, R&D and project teams.

Responsibilities include managing regulatory projects, preparing regulatory documents, and maintaining regulated data within PLM systems.

Qualifications

• Must have regulatory/compliance experience in FDA-regulated industries.
• Ability to prepare regulatory documents (MF statements, CoFS, registrations).
• Understanding of GMP/GCP concepts and regulations.
• Ability to review materials, formulas, packaging for compliance.
• Strong documentation and data management practices.

Responsibilities

• Provide regulatory support to chemists by reviewing formulas and materials.
• Deliver timely regulatory guidance to support product development and initiatives.
• Manage regulatory projects with limited oversight and milestones.
• Enter and review data in PLM systems for regulatory accuracy.
• Review materials, formulas and packaging for compliance with standards.
• Prepare regulatory documents for domestic and international markets.
• Compile documentation for customer requests and EU Product Information Files.
• Communicate with suppliers to obtain regulatory docs and clarify compliance questions.
• Evaluate alternate suppliers for regulatory compliance.
• Maintain regulatory files for audits and inspections.
• Support cross-functional teams with regulatory input on new concepts and claims.
• Develop and maintain standard operating procedures for regulatory processes.
• Provide regular project updates to stakeholders.

Skills

Regulatory compliance

FDA-regulated industry

Regulatory affairs

Documentation

GMP/GCP

Regulatory interpretation

Cross-functional collaboration

Communication

Attention to detail

Organizational skills

Education

Bachelor's degree in Chemistry, Biology, Engineering

Tools

Product Lifecycle Management (PLM) systems

Job description

Actalent is seeking a Regulatory Specialist to provide comprehensive regulatory support across product development, quality, and compliance. You will review formulas, materials, and labeling to ensure regulatory conformity for domestic and international markets, while collaborating with chemists, marketing, R&D and project teams.

Responsibilities include managing regulatory projects, preparing regulatory documents, and maintaining regulated data within PLM systems.