Product Compliance Specialist at Thermo Fisher Scientific

Carlsbad, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Chemicals, ManufacturingIndustries

Requirements

BS/MS degree in Chemistry, Toxicology, Biochemistry, Chemical Engineering, Law or related subject
Minimum 5 years regulatory experience in product stewardship / regulatory affairs / compliance / chemical consultancy / risk assessment
Experienced in all aspects of Americas chemical compliance (e.g., TSCA, CEPA, DEA)
Proficient user of reporting IT systems e.g. CDX
Has effectively worked with trade associations and/or sectorial advocacy group
Broad understanding of global chemical control regulations with a focus on the Americas
In-depth and operational understanding of chemical regulations
Experience working with regulatory agencies
Proficient in reading, interpreting, and implementing chemical regulations
Outstanding written and verbal communication skills, with the ability to present effectively in person, over the phone, in remote meetings, and in writing
Capable of engaging with individuals at all organisational levels
Strong data management and interpretation abilities, with proficiency in ERP systems and Microsoft Office
Excellent project management capabilities
Strong interpersonal skills including the ability to remain calm, professional and positive
Highly motivated, with strong organisational skills and the ability to prioritise multiple tasks simultaneously

Responsibilities

Manage all aspects of product chemical regulatory compliance for the Americas including USA, Canada & Brazil e.g. TSCA, CEPA & DEA
Provide technical oversight and direct support for all major filings e.g. TSCA PMN
Support manufacturing locations in CDR & TRI submissions
Develop, refine and maintain training material for educating team members & stakeholders on the company’s chemical compliance obligations
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
Assist in the development and implementation of policies, objectives, plans and procedures for chemical compliance programs
Be a proactive and effective communicator

Skills

TSCA

CEPA

DEA

TSCA PMN

CDR

TRI

CDX

Product Stewardship

Regulatory Affairs

Chemical Compliance

Risk Assessment

Regulatory Intelligence

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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