Regulatory Affairs Manager
- KEY RESPONSIBILITIES
- Ability to author Safety Data Sheets (SDS) and related hazard label content for a global product mix and maintain the master (computer) file.
- Expert knowledge of regulations affecting chemical manufacturing and distribution, including: EPA requirements; TSCA registration process; REACH registration; Hazmat shipping regulations; MITI, CEPA, CLP, CPSC, FHSA, CCPSA-CCCR, Korea ARECS, USMCA or other FTA forms and other foreign regulations.
- Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body
- Investigate specific client complaints / adverse experiences / operational problems to identify root cause and design effective corrective and preventive actions, as well as, responding to customer information requests related to specific regulatory issues.
- Actively support the maintenance and development of departmental knowledgebase for all material and product concerns.
- Prepare New Chemical Notifications in consultation with technical personnel for U.S. and other countries. File Notification of Commencement letters as needed.
- Prepare shipping and packaging guidelines for all hazardous materials.
- Coordinate toxicological testing of new and existing substances as required by TSCA, PMN process and/or foreign registration.
- Responsible for responding to customer requests relating to all regulatory issues and compliance questionnaires.
- Responsible for FDA requests to ensure customs/trade compliance
- Provide assistance in developing, implementing and maintaining Product Stewardship/Regulatory standards for new product development, review Product Stewardship procedures for plants and business groups, provide interpretation and training to end-users. Create documentation of internal processes and procedures.
- Assist in evaluating compliance with Product Stewardship standards and applicable laws and regulations. Assist in identifying and maintaining new requirements, provide information to business units and plants to elevate awareness, work with consultants and law firms.
- COIM USA, Inc. is seeking a Regulatory Affairs Specialist who will provide highly specialized review and assessment to Product Development, Brand & Marketing, Legal, and other departments from a regulatory compliance and product stewardship perspective. Ensure the coordination and effective communication with global compliance team members, engineers, program leads, and Brand personnel.
- Bachelor’s Degree in science or engineering, majoring in Chemistry, Chemical Engineering, Toxicology, or Environmental Science (M.S. in science or engineering a plus).
- Three to six (3 – 6) or more years’ experience in chemical and/or discrete manufacturing under a formal product regulatory discipline.
- Proficiency in Navision preferred
- Proficient in multiple platforms for data management including Microsoft Excel, Sharepoint, Teams and Sales Force
- Proficient with Microsoft Office (Outlook, Word, Excel) and Adobe Acrobat
- Proven project management skills, with the ability to handle multiple tasks/projects simultaneously.
- Must have direct experience reviewing and assessing Chemical Control Legislation and interacting with Global Competent Authorities.
- Exceptional written/verbal/interpersonal communication skills, which include technical/program writing, demonstrated training experience, and/or presentation abilities.
- Work collaboratively in a small group setting.
- Support and manage changing priorities and workloads.
- Deal tactfully with people
- Negotiate to maximize the benefits to the organization.
- Make oneself understood by others.
- Listen to suggestions of others.
- Effectively communicate complex topics at all levels within the organization and develop personal credibility.
The characteristics listed below are representative of the physical and environmental demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- Requires remaining in a stationary position for prolonged periods of time and frequent communication.
- Must be able to traverse and operate computer and other office equipment.
- Typical work is in an office environment where the noise level is low to moderate.
Learn more here
Job posted: 2021-03-13