Regulatory Specialist

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

Job Title: Regulatory SpecialistJob Description

The Regulatory Specialist provides comprehensive regulatory support across product development, quality, and compliance activities. This role reviews formulas and raw materials, interprets regulations, prepares regulatory documentation, and ensures that packaging and product information meet all applicable requirements. The position collaborates closely with chemists, marketing, innovation, R&D, and project teams to support strategic business initiatives and maintain robust regulatory compliance in an FDA-regulated environment.

Responsibilities

• Provide regulatory support to chemists by reviewing product formulas, evaluating raw materials, interpreting regulations, and offering general consultation.




• Support product development, customer service, and strategic business initiatives by delivering timely and accurate regulatory guidance.




• Manage assigned regulatory projects with limited oversight, ensuring milestones are met and deliverables are completed on schedule.




• Enter, review, and analyze information within the Product Lifecycle Management system to maintain accurate regulatory and product data.




• Review raw materials, product formulas, and applicable regulations to confirm compliance with relevant standards and requirements.




• Review packaging artwork to ensure it meets regulatory and customer requirements, including claims, ingredient listings, and labeling standards.




• Prepare regulatory documents such as Good Manufacturing Statements, Certificates of Free Sale, and registration materials for domestic and international markets.




• Compile documentation for customer requests and European Union Product Information Files, ensuring completeness and accuracy.




• Communicate with raw material suppliers to obtain regulatory documentation and clarify compliance-related questions.




• Evaluate alternate chemical suppliers from a regulatory perspective to ensure their materials meet internal and external compliance requirements.




• Enter and review product formulas within internal systems, maintaining consistency and alignment with regulatory guidelines.




• Maintain accurate, organized, and up-to-date regulatory files and records to support audits, inspections, and internal reviews.




• Support Marketing, Innovation, R&D, and project teams by providing regulatory input on new concepts, product claims, and market expansion.




• Develop and maintain standard operating procedures related to regulatory processes to promote consistency and continuous improvement.




• Provide regular project updates to stakeholders and help ensure assignments and regulatory tasks are completed on time.

Essential Skills

• Proven experience in regulatory compliance, with 1 to 3 years of experience required for Regulatory Specialist I.




• Background in an FDA-regulated industry such as cosmetics, pharmaceuticals, medical devices, or food.




• Strong understanding of regulatory affairs, regulatory compliance, and quality assurance principles.




• Ability to prepare and manage regulatory documents, including Good Manufacturing Statements, Certificates of Free Sale, and registration materials.




• Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) concepts as they relate to regulated products.




• Capability to review and interpret regulations and apply them to raw materials, formulas, packaging, and product claims.




• Proficiency in using internal systems and Product Lifecycle Management tools to enter, review, and analyze product and regulatory data.




• Excellent organizational skills with the ability to maintain accurate and structured regulatory files and documentation.




• Strong communication skills to collaborate with chemists, cross-functional teams, and raw material suppliers.




• Attention to detail and analytical skills for evaluating compliance risks and ensuring regulatory accuracy.

Additional Skills & Qualifications

• Bachelors degree in Chemistry, Biology, Engineering, or another scientific field.




• Experience with personal care, pet care, household, or industrial products is preferred.




• Ability to develop and maintain standard operating procedures for regulatory processes.




• Experience supporting cross-functional teams such as Marketing, Innovation, R&D, and project teams.




• Comfort working on multiple projects simultaneously with limited oversight while meeting deadlines.




• Strong problem-solving skills and a proactive approach to identifying and addressing regulatory issues.

Work Environment

The role is primarily based in a climate-controlled office environment, working with computers, internal systems, and documentation tools on a regular basis. The position may periodically require entering warehouse and manufacturing environments to support regulatory activities, observe operations, or review materials and processes. The work setting emphasizes collaboration with cross-functional teams and adherence to quality and regulatory standards.

Job Type & Location

This is a Contract position based out of Omaha, NE.

Pay and Benefits

The pay range for this position is $24.00 - $27.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Omaha, NE.

Application Deadline

This position is anticipated to close on Nov 6, 2026.

Workplace Type

This is a fully onsite position in Omaha,NE.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.