Regulatory Affairs Manager
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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.

Responsibilities

• 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

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

Compensation and Benefits
The salary range estimated for this position based in Maryland is $103,100.00-$154,700.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
  

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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