Documentation Specialist

Regulated SKU SME

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Scientific discovery begins with chemicals and leads to breakthroughs that improve lives. Our mission is to empower scientists to bring chemistry to life. We offer an extensive portfolio of chemicals and solutions that support nearly every laboratory need—from early research through drug discovery, development, and manufacturing. Your work here will create real-world impact, supported by opportunities to grow and achieve your career goals.

Position Summary

As a subject matter expert on Regulated SKU’s, the successful candidate will provide collaborative, cross-functional support and coordinate projects requiring deep knowledge of chemical regulations and compliance. Key responsibilities include maintaining, enhancing and harmonising our Regulated SKU management across multiple sites, supported by fit for purpose work instructions.

This role will also oversee the implementation and maintenance of internal tools and software systems supporting chemical regulatory compliance.

Ideal applicants will bring a strong understanding of global chemical control frameworks (e.g., REACH, TSCA) and familiarity with biocides, microplastics, and major international conventions. We are seeking someone with hands-on experience working with regulatory authorities, who enjoys solving complex challenges. If that sounds like you, Thermo Fisher Scientific invites you to help us fulfil our mission to make the world healthier, cleaner, and safer.

Responsibilities

• Active management, maintenance and enhancement of our Regulated SKU database across all sites.
• Harmonise Regulated SKU process across all sites.
• Manage, improve and audit work instructions across all regulated SKU’s order management processes.
• Develop, improve, and maintain training resources and records for our regulated SKU portfolio.
• Lead and deliver key projects aligned with strategic priorities.
• Offer regulatory guidance to internal and external stakeholders.
• Implemention and change management control for emerging legislation, regulatory changes and new jurisdictions.
• Support the development and execution of policies, objectives, and procedures for chemical compliance programs.
• Monitor and evaluate emerging legislation and participate in associated risk assessment activities.

Required Qualifications

• BS/MS in Chemistry, Toxicology, Biochemistry, Chemical Engineering, Law, or a related field.

Experience

• At least five years of regulatory experience in product stewardship, regulatory affairs, compliance, chemical consulting, or risk assessment.
• Proven experience with EU chemical regulations, including EU REACH, drug precursor and explosive precursor regulations, Prior Informed Consent, CLP, and ODS & F-gas regulations.
• Proficiency with software tools to support Regulated SKU management and process harmonisation.
• Previous engagement in trade associations or sector advocacy groups.

Knowledge, Skills, and Abilities

• Ability to interpret, apply, and operationalize chemical regulations.
• Strong written and verbal communication skills, including effective presentation abilities across in-person and remote formats.
• Ability to engage and collaborate effectively at all organizational levels.
• Strong interpersonal skills with a calm, professional, and positive approach.
• Ability to thrive in a fast-paced environment and work both independently and as part of a team.
• Highly motivated, well-organized, and capable of managing multiple priorities simultaneously.
• Advanced project management skills with a history of delivering programs on time and within budget.

Experience Level

Mid Level