Regulatory Affairs Manager

Job Details

Job Ref:
REGUL003511
Location:
505 Central Ave, Pawtucket, RI 02861
Category:
Regulatory Affairs
Employment Type:
Full Time

Overview

    When Alfred Fain founded a small Rhode Island tire store in 1924, at the time no one could have predicted how Teknor Apex would become an international custom compounder sought out by companies around the world. After a nearly hundred-year journey that’s carried us through acquisitions and expansion, we now have nine U.S. locations, as well as operations in Belgium, Singapore, Germany, and China.

    Throughout this global expansion Teknor has remained a privately held company, and today Fain’s grandson sits at the helm, maintaining the family’s tradition of fostering deep employee and customer relationships. These relationships are what allow us—together—to deliver customized compound solutions and help our customer’s create better products.

    “Manufacturing is a team sport, and we work together to achieve our goals.”  ~Jon Fain

    Essential Duties and Responsibilities:

    This position manages Product Regulatory Specialists to provide customers, government agencies, and third party certification organizations with information for both domestic and international regulations for finished goods from all company divisions. They also coordinate development of product data required for regulatory compliance.

    Essential Functions:

    • Manages Product Regulatory Specialists responsible for issuing regulatory certification letters for external customers.
    • Maintains corporate product formula restriction programs and authorizes formula revisions.
    • Oversees management of relationship with various regulatory agencies such as, FDA, NSF, EPA, OSHA, DOT, State Regulatory Agencies, International agencies, etc. in support of TA Business interests.
    • Interprets existing Domestic and Global Regulations for their effects on TAC.
    • Develops data and assesses impacts of new regulations on TA businesses.
    • Coordinates support activities and provides information to internal customers
    • Conducts regulatory presentations to educate internal personnel and external customers on regulatory matters.
    • Performs additional duties and responsibilities as assigned.
    • Maintain compliance with all company policies and procedures

     

    Other Essential Functions:

    • Position has no budget responsibilities and no revenue responsibilities.
    • Responsible for a team of exempt-level direct reports

     

    Education and/or Work Experience Requirements:

    • Work is broad in scope covering new or more complicated areas. Policy, procedure, or precedent is typically created by this position.  A high degree of analytic ability and inductive thinking is required to devise new or more technically complex problems.
    • Experience working with regulatory databases, including understanding of compliance algorithms.
    • Ability to develop plans to comply with new or revised regulations.
    • Excellent verbal and written skills are required.
    • Ability to work in cross functional business teams
    • Knowledge of product regulatory systems and risk management, Knowledge of other product regulatory requirements, Knowledge of Enterprise, Quality and Regulatory Systems, Knowledge of Chemistry, Raw Materials, and global regulatory requirements relevant to Teknor Apex businesses.
    • Position requires between 6-8 years of regulatory experience, with 2-3 years supervisory experience.
    • Experience with new chemical regulations such as substance notifications/registrations in the US, and other jurisdictions, or experience working with FDA, EPA, or NSF, preferred.
    • Experience working with Enterprise Resource Planning (ERP) system, M3 desired, including an understanding of product data architecture.
    • Experience authoring GHS SDS’s, including knowledge of GHS regulatory requirements outside of North America.
    • Four-year degree or equivalent experience in a field of study such as chemistry, biology, toxicology or engineering, etc.
    • Advanced degree, desired.

    This description is a summary of principal responsibilities and is not intended to include all duties that may be assigned.

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