Senior Regulatory Affairs Specialist

Responsibilities

• Primary liaison with regulatory agencies (USDA, FDA) and Importer of Record for USA
• Works autonomously on complex regulatory files and on own specialized projects
• Prepares various regulatory documents as required by customers (e.g., Letters of Guarantee, Prop 65 Statement, EDQM’s)
• Prepares FDA/USDA shipment Affidavits
• Manages technical files/dossiers and guides cross-functional R&D and quality teams to meet all global statutory requirements
• Proactively navigates global import/export requirements for all applicable products
• Maintains accurate regulatory statements to ensure global compliance
• Effectively represents Regulatory Affairs on project teams and provides regulatory guidance
• Reviews documents for regulatory compliance
• Prepares submissions to regulatory authorities
• Communicates importance of Regulations and Compliance
• Works effectively in a team environment to ensure individual tasks, team, and department objectives are achieved
• Communicates progress on regulatory projects
• Projects professionalism and a cooperative demeanor

Requirements

• Bachelor of Science degree in Chemistry, Food Science, Regulatory Affairs, or equivalent
• Minimum of 3 years of experience in a regulatory environment, preferably food, pharmaceutical, health and nutrition, pet food/feed
• Experience working with U.S. government agencies such as FDA, USDA/APHIS with food, pharma and/or pet food/animal feed
• Strong understanding of CFIA regulations and imports/exports
• Understanding and guidance of Kosher and Halal certifications and regulations
• Knowledgeable on labeling and claims compliance of all products

Preferred Qualifications

• Master’s degree preferred

Skills & Physical Demands

Interpersonal Skills:

• Strong organizational and time management skills
• Ability to work effectively with diverse groups of associates at all levels of the organization and customers

Language Skills:

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions
• Strong communication skills, both oral and written, including attention to detail

Mathematical Skills: