More jobs:
Regulatory Compliance Lead
Job in
Houston, Harris County, Texas, 77246, USA
Listed on 2026-01-10
Listing for:
Airbus
Full Time
position Listed on 2026-01-10
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Job Description & How to Apply Below
** Your Role & Responsibilities**## ##
*
* Job Summary:
** The Regulatory Compliance Lead will oversee the daily operations and strategic development of the Regulatory Compliance and Document Management function across North America, with growing interaction with LATAM. This role manages a team responsible for product setup, supplier documentation, Trace Gains management, and regulatory surveillance activities, ensuring accuracy, compliance, and efficiency in supporting customer and supplier documentation needs.
The ideal candidate possesses strong regulatory knowledge, leadership experience, and a working understanding of product compliance systems. This individual will also represent the team in higher-level regulatory discussions, customer calls, and cross-functional initiatives to harmonize compliance processes and enhance documentation performance across regions.##
*
* Job Description:
**** Leadership and Oversight
*** Lead a team responsible for product setup, supplier documentation management, Trace Gains oversight, and document approvals.
* Ensure consistent application of documentation and regulatory standards across all product categories and systems.
* Serve as the primary escalation point for document-related issues and regulatory concerns.
* Develop and monitor metrics related to document turnaround time, accuracy, and compliance rates.
* Mentor and coach team members to build technical and regulatory competency.
** Regulatory Compliance and Documentation Management
*** Oversee document acquisition, review, and approval for all supplier and Brenntag-generated documents.
* Manage Trace Gains workflows for supplier document control, ensuring compliance for active materials.
* Coordinate document requests from customers and ensure prompt responses through efficient communication and prioritization.
* Support product removal/deletion and change notification processes, including supplier updates and specification revisions.
* Monitor expired or missing documents and ensure proactive resolution.
** Regulatory Intelligence and Product Compliance
*** Track and communicate relevant regulatory changes across North America and LATAM.
* Support compliance with FDA, Health Canada, ANVISA, and related regional frameworks.
* Collaborate with regional Regulatory Affairs and Quality Assurance teams to interpret and implement new regulatory requirements.
* Partner with Product Management and R&D to ensure specifications align with current regulatory expectations.
** Cross-Functional and Customer Engagement
*** Represent Regulatory Compliance in customer-facing meetings and provide regulatory documentation or statements as needed.
* Collaborate with Sales, Quality, and Commercial to ensure all documentation supports customer expectations and supplier standards.
* Partner with the appropriate departments to ensure supplier compliance and documentation accuracy.
* Facilitate communication and document flow between proactive (Regulatory Compliance) and reactive (Regulatory Services) teams to prevent redundancy and improve efficiency.
** Systems and Process Optimization
*** Maintain alignment between Trace Gains, ERP, and SharePoint systems for document traceability and version control.
* Drive digital improvement initiatives, automation, and harmonization of documentation processes.
* Develop and deliver internal training on documentation workflows, Trace Gains use, and regulatory standards.# #
** Your Profile**## ##
*
* Education and Experience:
*** Bachelor’s or Master’s degree in Regulatory Affairs, Chemistry, Biology, Food Science, or related field.
* 7+ years of experience in Regulatory Affairs, Documentation Management, or Quality Systems within food, chemical, or cosmetics industries.
* Strong understanding of North American regulatory frameworks (FDA, Health Canada, etc.); exposure to LATAM a plus.
* Proven ability to manage and develop high-performing teams.
* Experience with documentation management tools such as Trace Gains, SharePoint, or ERP systems.
* Exceptional communication and organizational skills; customer-facing experience strongly preferred.
* Proficiency in Spanish, French, or Portuguese a plus.
* Minimal (
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