Job Details

Regulatory Affairs And Technical Services Director

Company name

Lebermuth, Inc

Organization Type

In-House

Job Type

Legal Staff

Date Last Verified

Sep 22, 2020

Valid Through

Jan 05, 2021

Posted on

Jul 31, 2020

Years of Experience

Min 7 yrs required

Location

South Bend, IN, United States

Employment Type

Full-time

Industry

Legal
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Regulatory Affairs And Technical Services Director
The candidate will be responsible for: Develop, implement, and maintain policies and programs to execute regulatory objectives; maintain Company SOP documents. Establish the strategic direction of the department, consistent with the Company’s short and long-term objectives, regulatory compliance initiatives including auditing, management of corrective actions and regulatory documentation. Identify and troubleshoot process deviations and suggest effective corrective and preventative actions and lead and author key investigation reports by closely working with Manufacturing, Quality Assurance, Quality Control, and other relevant stake holders. Manage, Mentor, and provide strategic leadership and support to build and develop high performing Quality Control and Regulatory teams, capable of meeting the required business, operations, and quality targets. Lead and champion regulatory programs and teams in support of maintaining and improving company reputation and brand identity, with a focus on risk mitigation and continual improvement. Consult and coordinate with various Company departments and business units on compliance initiatives. Facilitate the effective exchange of regulatory information between the Sales, Manufacturing, Regulatory, QC, R&D and Purchasing departments to drive company-wide or cross-departmental initiatives. Review and interpret regulatory rules as they relate to Company products and procedures, testing or record keeping, and ensure they are communicated throughout the Company. Provide regulatory guidance to company departments (i.e. Sales, QC, R&D, Manufacturing). Responsible for coordinating the preparation and submission of regulatory documents to customers and other external parties. Remain current on industry-specific document management techniques, with the goal of continuous improvement. Ensure accurate, compliant preparation and timely submission of documents required by customers, suppliers, and governmental agencies. Execute effective strategy for compliance with all applicable Company and governmental requirements, including but not limited to, SQF, GMP, HACCP, FSMA, OSHA and USFDA. Manage internal and external audits, regulatory agency inspections and communications. Manage internal and external audits, regulatory agencies inspections and communications as they pertain to Organic, Kosher and DEA. Investigate product complaints and prepare documentation for regulatory agencies, as necessary. Maintain current knowledge of existing and emerging regulations, standards and guidance documents as related to IFRA, Kosher, and Organic. Interacting with regulatory agencies frequently, including the FDA, USDA, EPA, DEA and OSHA. Organize and deploy training for regulatory personnel on processes/procedures, and tasks related to the regulatory department. Ensure communication and coordination between Tech Services and SLT members. Drive strong collaboration and communication across Operations, Quality and Product Development teams on regulatory matters. Provide support to the SQF Practitioner as needed for audit compliance requirements. Continually strive to promote a safe food culture, ensuring the production and shipment of safe quality food products%. Other duties, as assigned. Must have experience in Flavor or Fragrance Industry. Master’s degree required and PhD preferred, with concentration of studies in Chemistry, Chemical Engineering, or similar field of study. Experience supporting Laboratory Services and Regulatory Affairs. Experience in an SQF environment preferred. Natural progression of 7+ years of on-the-job experience that has led to a Regulatory or Technical professional, and a minimum of 2-3 years of proven leadership experience with strong coaching and staff development skills. Must have ability to read, analyze and interpret professional journals, technical procedures, scientific data, governmental regulations, and chemical hazard information and safety procedures. Should have working knowledge and experience with regulatory-related programs. Proficiency with Microsoft Office products.

Company info

Hiring Coordinator
Lebermuth, Inc
4004 Technology Dr.
South Bend, IN 46628

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