What are the responsibilities and job description for the Regulatory Compliance Specialist position at Movement Search & Delivery?
Movement Search and Delivery is currently working with a manufacturer of specialty materials, chemicals, food ingredients, and healthcare products to customers throughout North America.
About the role:
The Specialist is responsible for providing product stewardship and product regulatory compliance services for the products in Texas and other international locations, serving customers both internal and externally. This role supports product and regulatory compliance activities across FDA food contact, hazard communication (SDS/GHS), TSCA, and international chemical control regulations, and serves as a subject-matter resource to management on product stewardship and regulatory risk, including risks associated with mergers and acquisitions and new business ventures.
What You Will Do:
FDA
- Accurately interpret food contact regulations related to the polymer products that our client produces or imports into the US.
- Prepare Food Contact Notifications (FCNs) for submission to the FDA for new or existing products.
- Coordinate efforts in obtaining “opinion letters” from FDA counsel.
- Prepare food contact application statements based on the Code of Federal Regulations as it relates to the polymer products that our client produces or imports into the US.
- Prepare migration testing protocols for new polymers.
- Prepare and maintain Drug Master Files for polymer products used in pharmaceutical packaging.
Hazard Communications (SDS/GHS)
- Prepare and maintain GHS SDSs for products and intermediate materials.
- Prepare and maintain GHS SDSs for business entity products and intermediate materials as needed.
- Prepare GHS-compliant hazard classifications and label content for product containers.
TSCA
- Investigate TSCA status of products and imported raw materials.
- Prepare Pre-Manufacture Notices (PMNs) for new or existing products.
- Prepare polymer exemption reports (PERCs).
- Maintain records to know when PMNs and PERCs are needed and prepare end-of-year (EOY) reporting documents for polymer exemptions filed for polymers imported or manufactured the prior year.
- Prepare annual reports for TSCA 12(b) notification to the EPA and oversee other required reports. Support other business entities in this area as needed.
International & Other Registrations
- Assist with preparing New Substance Notifications (NSNs) as required to introduce new products into Canada.
- Assist with the certification of products for use in food contact applications in the EU under REACH.
- Prepare Food Certification documents for polymer products that our client produces or imports into the European Union for compliance with European Commission.
- Assist in getting products registered under other countries’ chemical control laws as needed.
- File information requests with NSF to assist business entity products in being approved for new applications.
- Maintain documentation necessary to demonstrate compliance with these subjects.
Advisory & Business Support
- Assess product stewardship issues and risk related to M&A activities and advise management.
- Support new business ventures and provide leadership in aligning new venture product stewardship management.
- Provide technical guidance and mentoring to less experienced staff supporting product stewardship functions.
- Partner with the Trade Compliance function to provide product regulatory data (e.g., TSCA import certification status, hazard classifications) supporting customs and transportation compliance.
What You Need to Succeed:
- Bachelor’s Degree in Chemistry, Toxicology, Pharmacology, OR Chemical Engineering
- 7 years of experience in Product Stewardship/Regulatory Affairs with the Chemical industry.
- Direct experience with FDA Food contact and TSCA new chemical submissions.
About Movement Search and Delivery
MOVEMENT is a national executive search firm that connects companies with exceptional talent across engineering, manufacturing, finance, supply chain, information technology, sales, legal, and human resources.
How to Apply
Apply through this posting and a member of the Movement Search and Delivery team will review your application. For more information on open jobs, visit www.movementsearch.com.