Senior Regulatory Affairs Specialist

Bakery Feeds, by Darling Ingredients • Irving, TX

1d

About The Position

The Senior Regulatory Affairs Specialist serves as a primary liaison with U.S. regulatory agencies, including the USDA and FDA, and the U.S. Importer of Record. The role independently handles complex regulatory files and specialized projects, prepares customer regulatory documents and FDA/USDA shipment affidavits, and manages technical files and dossiers. The specialist guides cross-functional R&D and quality teams to meet global statutory requirements, navigates import/export requirements, and maintains accurate regulatory statements to support global compliance.

The specialist represents Regulatory Affairs on project teams by reviewing documents for compliance, preparing submissions to regulatory authorities, communicating the importance of regulations and compliance, and keeping teams informed of project progress. The position works collaboratively to advance team and departmental objectives and requires professionalism and a cooperative demeanor.

The role requires strong organizational, time-management, communication, analytical, and interpersonal skills, along with knowledge of database, internet, spreadsheet, and word-processing software. Travel is approximately 10%. The employee may occasionally perform physical activities such as standing, walking, handling or feeling objects, reaching, climbing or balancing, stooping, kneeling, crouching, crawling, and tasting or smelling; occasional lifting or moving of up to 10 pounds is required. Potential environmental exposures include wet or humid conditions, moving mechanical parts, chemicals, outdoor weather, and electrical environments.

Requirements

• Bachelor of Science degree in Chemistry, Food Science, Regulatory Affairs, or equivalent.
• At least 3 years of experience in a regulatory environment; food, pharmaceutical, health and nutrition, or pet food/feed experience is preferred.
• Strong understanding of CFIA regulations and imports/exports.
• Understanding of and ability to provide guidance on Kosher and Halal certifications and regulations.
• Knowledge of product labeling and claims compliance.
• Strong organizational and time-management skills.
• Ability to work effectively with diverse groups of associates at all organizational levels and with customers.
• Ability to read and interpret business periodicals, professional journals, technical procedures, and governmental regulations; write reports, business correspondence, and procedure manuals; and present information and respond to questions effectively.
• Strong oral and written communication skills and attention to detail.
• Ability to follow written, oral, or diagrammed instructions and address problems involving several concrete variables in standardized situations.
• Knowledge of database, internet, spreadsheet, and word-processing software.
• Ability to travel approximately 10% of the time.
• Ability to occasionally stand, walk, handle or feel objects, reach, climb or balance, stoop, kneel, crouch, crawl, and taste or smell; occasionally lift or move up to 10 pounds.
• Ability to work in environments that may include wet or humid conditions, moving mechanical parts, chemicals, outdoor weather conditions, and electrical environments.

Nice To Haves

• Master’s degree.
• Experience working with U.S. government agencies such as FDA or USDA/APHIS in food, pharmaceutical, or pet food/animal feed contexts.

Responsibilities

• Serve as the primary liaison with U.S. regulatory agencies, including USDA and FDA, and the U.S. Importer of Record.
• Independently handle complex regulatory files and specialized projects.
• Prepare customer regulatory documents, such as Letters of Guarantee, Prop 65 statements, and EDQM documents.
• Prepare FDA/USDA shipment affidavits.
• Manage technical files and dossiers and guide cross-functional R&D and quality teams in meeting global statutory requirements.
• Navigate global import and export requirements for applicable products.
• Maintain accurate regulatory statements to ensure global compliance.
• Represent Regulatory Affairs on project teams and provide regulatory guidance.
• Review documents for regulatory compliance.
• Prepare submissions to regulatory authorities.
• Communicate the importance of regulations and compliance.
• Work collaboratively to meet individual, team, and department objectives.
• Communicate progress on regulatory projects and maintain a professional, cooperative demeanor.
• Travel approximately 10% of the time.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior