Product Regulatory Compliance Manager

2 weeks ago

North Kingstown Rhode Island, United States Fujifilm Full time

Overview:
Who We Are


FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe.

We have an exciting opportunity at our North Kingstown, Rhode Island facility for a Product Regulatory Compliance Manager


With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process.

The Role

The Product Regulatory Manager is a key member of Fujifilm Electronic Materials U.S.A. who works with business leaders to drive product regulatory compliance while enabling growth.

This position is responsible for the product regulatory compliance of Company products marketed and sold in North America and other regions including Europe and Asia.

The position is responsible for providing internal and external customer product regulatory and safety support including matters dealing with regulatory agencies in the USA.

This role will have the responsibility for leading and providing oversight to the product regulatory function through the development and implementation of standard processes to ensure compliance, establishing and leveraging best practices and initiatives to support and enable business objectives.

This role will also monitor and analyze regulatory trends and initiatives and address customer-driven product stewardship needs across the business segments.


External US:

Key responsibilities for this role include:
Oversee performance and compliance against regulatory requirements, business objectives, internal company requirements, and regulations.

Maintain expertise knowledge of EPA requirements for new chemical registrations and existing chemical reporting


Ensure that all Company products are compliant with applicable regulations for the USA and any other regions to which they are sold.

For the US, this includes screening for EPA compliance and preparing and submitting appropriate documentation (Low Volume Exemption (LEL) and Pre-manufacturing Notice (PMN)) to register new substances, and to monitor compliance.

This also includes maintaining databases of such filings. Awareness of DEA and DOT requirements is also needed.


Globally maintain awareness of changing regulations for chemical registration and SDS's and assist in the proper registration of components for the country involved.

A subset of this is the generation of the appropriate SDS's for any new products, and the updating of existing SDS's.

This includes product label generation and approval.

In coordination with the business teams, develop product registration strategies in support of new product introductions.

Provide regulatory review assessments during new product development

Assess business impact to new product launches related to product regulatory approvals.

Monitor relevant regulatory activities that may impact Fujifilm Electronic Materials U.S.A. Generate and clearly communicate impact assessments and other information as appropriate.

Monitor changes in chemical regulatory activity and identify non-compliance issues or risks.

Manage direct reports

Provide guidance to the business and appropriate functions on how new laws, regulations or legislation will impact our business operations and overall strategy

Respond to customer-driven product stewardship needs across the segments.

Provide chemical management support to Manufacturing plants and laboratories.

Support product labeling requirements.

Provide guidance to affiliate regulatory teams to ensure alignment across regions.

Interact with both US and Foreign Nationals as needed to address appropriate regulatory issues


Represent the company in select industry groups and as a representative to government agencies to represent Fujifilm Electronic Materials position on relevant issues.

Lead efforts to identify and implement best practices to drive consistency and efficiency across the function for continuous improvement

Develop leading and lagging indicators to track performance and understand trends to improve functional efficiency or effectiveness.

Ensure the necessary information systems and tools are in place and maintained to meet requirements for compliance and business support


Ensure that all department functions are documented in standard operating procedures, work instructions, and support documents including periodic document review and updates as appropriate.

Support projects to improve overall company performance through the implementations or upgrades to the corporate SAP system.

Recommend programs and plans and coordinate with other regions as necessary for regulatory compliance and commercial success.

This position also functions as the Chemical Hygiene Officer for the R&D organization.

REQUIREMENTS
Master's or PHD in chemistry

Experience or training is required in chemistry, both organic and inorganic, with the ability to perceive chemical interactions that may necessitate new substance filings; Polymer chemical background is preferred

5-8 years of work experience in a product stewardship role

Knowledge of EPA requirements for chemical registrations and reporting.

Work experience in the semiconductor materials industry

Global experience

Direct managerial responsibility experience

Thorough knowledge of product regulations, enforcement and industry practice relevant to the chemical industry

Basic computer programs (Excel, Word, PowerPoint, SAP) are required

This is a safety-sensitive position that requires candidates to successfully pass a post-offer drug screening prior to employment.

One of the essential job functions is the ability to work in a constant state of alertness and in a safe manner.

MENTAL & EMOTIONAL
REQUIREMENTS


Resilience - Adapting well in the face of workplace stressors, the ability to work effectively and efficiently in high stress and conflict situations, the ability to remain poised under all circumstances, the ability to maintain regular attendance and be punctual.


Communication - The ability to successfully and professionally express and exchange ideas and meanings with all levels of employees in the organization, the ability to interact appropriately with a variety of individuals including customers/clients, the ability to work as an integral part of a team, ability to interact effectively with people in a positive manner that engenders confidence and trust.


Reasoning and decision-making - The ability to understand, remember and follow verbal and written instructions, the ability to reason logically and make sound decisions.

Comprehension - The ability to complete tasks without direct supervision, the ability to simultaneously address multiple complete problems.


Organizational skills - Ability to multitask without loss of efficiency or accuracy, the ability to work and sustain attention with distractions and interruptions, the ability to perform in situations requiring speed, deadlines or productivity quotas.


FUJIFILM Electronics Materials, U.S.A., Inc., is part of the Fujifilm family – a company that has been evolving and transforming for more than 85 years.


Fujifilm is focused on four strategic business areas:
Advanced Materials, including electronic materials for semiconductor manufacturing; Imaging; Healthcare; and products and services to support Business Innovation. As a global company, Fujifilm has revenues of $21 billion, with 310 group companies and 73,275 employees worldwide.

FUJIFILM Electronic Materials, U.S.A., Inc. is an equal opportunity and affirmative action employer.

All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.


To all agencies:
Please, no phone calls or emails to any employee of Fujifilm about this requisition.

All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place.

In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

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