Regulatory Specialist presso COLORTECH INC

Description

Position Summary

The Regulatory Specialist supports the Regulatory Affairs department by ensuring that raw materials consumed and finished products produced/sold are in regulatory compliance. This position serves as the primary support to the Product Stewardship and Sustainability Manager, assisting with product compliance, data management, sustainability reporting, and document control.

Essential Job Duties/Responsibilities

Regulatory Documentation and Compliance:

• Generate, maintain, and provide product regulatory documentation, including food contact statements, compliance letters, USMCA certificates, and Safety Data Sheets (SDSs), for customers.
• Prepare and submit regulatory filings to authorities, including Drug Master File (DMF) and Health Canada Letter of No Objection (LONO) submissions.
• Support customer product certification requests (e.g., BPI Compostability, DIN CERTCO, NSF International, etc.).
• Ensure timely updates and responses to on-demand requests.
• Communicate with suppliers to request and collect required documentation in support of regulatory and quality compliance.
• Review supplier documentation (e.g., SDS, declarations, compliance certificates, etc.) to ensure compliance with internal and customer regulatory requirements.
• Coordinate with Procurement, Product Development, and Technical Services to ensure regulatory requirements are met for materials/products.

Data Management, Analysis, and Continuous Improvement:

• Maintain accurate regulatory data within company systems and databases (e.g., ERP and SDS software)
• Support and initiate process improvements to enhance data accuracy, reporting efficiency, and system integration.
• Monitor and assess regulatory and sustainability developments to determine potential impacts on materials, products, or operations.
• Prepare reports, summaries, and data analyses for internal and external regulatory submissions.
• Other duties as needed for support of regulatory and sustainability.

Sustainability Support and Cross-Functional Collaboration

• Assist in collecting and maintaining data for Colortech’s sustainability programs, including Scope 1, 2, and 3 GHG emissions, CDP, and EcoVadis reporting.
• Cross-train with administrative team members to ensure continuity in document management, reporting, and communication.
• Communicate effectively with internal personnel, suppliers, and customers to ensure alignment and timely exchange of information.
• Support cross-functional teams including Supply Chain, Shipping, Sales, and Customer Service by providing regulatory support for compliance operations.

Supervisory Responsibilities:

No direct supervisory responsibility but provides functional or technical guidance to other staff within a work group or unit.  May be required to provide some advice on policies and procedures to staff.

Required Skills/Abilities

• Requires application of knowledge in a specialized field. Ability to plan & organize work. Capable of solving problems of a complex nature within field of specialization.
• Working knowledge of Regulatory Affairs related to plastics and colorants is preferred.

Education and Experience

• Bachelor's Degree in an Engineering Discipline, preferably with an emphasis on Chemistry.
• Experience in a manufacturing environment, preferably within the polymer or chemical industry, in a regulatory affairs or sustainability role is strongly preferred.

Other Duties

Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Effort Required in the Position

Mental:

Constant analytical support to assess situations and respond appropriately. Experience constant requirements for lengthy periods of concentration. Work involves considerable demands to cope with changing priorities and to resolve conflict and handle crisis situations. Involves using considerable initiative, creativity, and innovation to perform job tasks.

Physical:

Audio Attention Required (when using equipment) – Moderate

Visual Attention Required (when using equipment) – Moderate

Lifting or Moving Objects and/or reaching and bending in awkward positions and/or climbing – Limited

Lifting or Moving Intensity – Limited

Mobility - remain in a seated or standing position – Limited

WORKING CONDITIONS SPECIFIC TO THE POSITION

Adverse Conditions (noise, heat, cold, dirt, fumes, and unpleasant environments) – Limited

Isolation – Physically removed from other staff – Limited

Exposure to Accident or Health Hazards – Limited

Local Travel - Limited

Overnight Travel – Limited

Key for Physical Effort and Working Conditions

Based on % of Time Involved:

                                                Limited -                      up to 25%

                                                Moderate -                  26% - 50%

                                                Considerable -             51% - 75%

                                                Constant -                   76% – 100%

Qualifications