Regulatory Affairs Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

Scientific journeys begin with chemicals and end with life enriching results. We enable scientists to bring chemistry to life, providing a broad range of chemicals and solutions supporting virtually every laboratory application, from research to drug discovery and development to manufacturing. Your work will have real-world impact, and you’ll be supported in achieving your career goals

POSITION SUMMARY

Acting as a subject matter expert, the applicant should have a broad understanding of global chemical control regulations such as REACH, TSCA, etc. and familiarity with biocide laws, and international conventions. If you thrive on working with a multinational team on diverse challenges, Thermo Fisher Scientific would like you to help fulfil its mission to enable our customers to make the world healthier, cleaner and safer.

REQUIRED QUALIFICATIONS

• BS/MS degree in Chemistry, Toxicology, Biochemistry, Chemical Engineering, Law or related subject

EXPERIENCE

• Minimum 5 years regulatory experience in product stewardship / regulatory affairs / compliance / chemical consultancy / risk assessment
• Experienced in all aspects of TSCA compliance. Proficient user of CDX
• Experienced in CEPA implementation, Prop 65, FIFRA application
• Has effectively worked with trade associations and/or sectorial advocacy groups
• Experience in multiple aspects of product stewardship, including risk assessment, hazard classification & labelling and other related topics

Knowledge, Skills, Abilities

• Ability to read, interpret and operationalize chemical regulations
• Excellent written, verbal communication and presentation skills. Ability to communicate clearly, succinctly and effectively in person, over the phone, on remote meetings and in writing
• Able to connect with all levels within the organization
• Strong data management and interpretation skills - proficient user of ERP systems & Power BI
• Strong interpersonal skills including the ability to remain calm, professional and positive
• Ability to work as a member of a multinational team in a fast-paced environment with moderated supervision
• Highly motivated, possessing strong organisational skills and able to prioritise multiple activities concurrently

• Manage all aspects of US Region product chemical regulatory compliance
• Provide technical oversight and direct support for all major filings e.g. TSCA CDR
• Serve as expert business liaison across the organisation
• Develop, refine and maintain training on corporate standards for meeting the company’s chemical compliance obligations
• Support ODS filings to EPA
• Manage and deliver on all key projects supporting key strategic imperatives
• Interpretation and application of information on local, regional, and global regulatory intelligence and other related information.
• Provide regulatory support to internal and external customers including proactive engagement with the R&D teams to seek innovative solutions to reducing product and or process hazards
• Support Product Lifecycle Management tools and requirements
• Be a proactive and effective communicator