Senior Regulatory Affairs Specialist

Essential Duties/Responsibilities

Regulatory:

• Primary liaison with regulatory agencies (USDA, FDA) and Importer of Record for USA.
• Works autonomously on complex regulatory files and on own specialized projects.
• Knowledgeable in the requirements for placing innovative products on the market, such as dietary ingredients and food and feed additives, as well as labeling (including structure-function claims, the related scientific supporting evidence, and product formulation) and advertising.
• Prepares various regulatory documents as required by customers (i.e. Letters of Guarantee, Prop 65 Statement, EDQM’s, etc.)
• Prepares FDA/USDA shipment Affidavits.
• Strong understanding of CFIA regulations and imports/exports.
• Understanding and guidance of Kosher and Halal certifications and regulations.
• Manages technical files/dossiers and guides cross-functional R&D and quality teams to meet all global statutory requirements.
• Proactively navigates 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 as outlined below:
• Reviews documents for regulatory compliance.
• Prepares submissions to regulatory authorities.
• Communicates importance of Regulations and Compliance.
• Represents the company with regulatory agencies.
• Works effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
• Communicates progress on regulatory projects.
• Projects professionalism and a cooperative demeanor.
• Ability to travel up to 20% domestic, occasional international

Minimum Qualifications

Education and/or Experience:

• A minimum of 3 years of experience in a regulatory environment, preferably food, pharmaceutical, health and nutrition, pet food/feed.
• A Bachelor’s degree in Chemistry, Food Science, Regulatory Affairs or equivalent required.
• Experience working with any of the U.S. government agencies such as FDA, USDA/APHIS with food, pharma and/or pet food/animal feed preferred.

Preferred Qualifications:

• A Master’s degree in Chemistry, Food Science, law or equivalent preferred.

Additional Skills and 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: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills: To perform this job successfully, an individual should have knowledge of Database, Internet, Spreadsheet and Word Processing software.