Regulatory Affairs Manager - St. Charles, Missouri

Summary 

The Regulatory Affairs Manager is responsible for oversees the day to day regulatory activities for AFB International in North America.  Responsibilities are varied and include coordinating the timely preparation and submission of technical information to our customers and regulators, maintaining state and federal registrations and licensing, import and export certifications, trade association representation, etc.  Influential leadership skills are important as the role also acts as a resource to guide the data to day activities of the Regulatory Affairs Associates for North America.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Drafts, maintains, and updates regulatory guidelines, positions, SOPs for the department.
  • Refreshes training for current regulatory affairs associates and trains new associates.
  • Coordinates new ingredient approvals, AAFCO new definition approvals, etc., as required by the business.
  • Represents AFB International on assigned committees in relevant trade associations.
  • Oversees state product registrations, licensing, tonnage fee reporting, and inspection fee payments.
  • Compiles and coordinates regulatory information for product labels, import/export, and product characteristics for usage by internal and external customers.
  • Conducts internal audits to ensure accuracy and regulatory compliance for product labeling, licenses, and food safety/defense.
  • Prepares export certificate documents for international samples and commercial shipments.
  • Maintain and updates records relating to international and domestic regulations for finished products and raw materials.
  • Works in partnership with manufacturing and QA/QC in enhancing quality management systems to facilitate overall regulatory compliance.
  • Interacts with various internal and external customers as well as regulatory bodies at the state and federal level.
  • Provides regulatory documents in compliance with customer and country-specific requirements.
  • Maintain USDA certification for the manufacturing facilities pursuant to European Union (EU), China, Australia, and Canada regulations.
  • Maintains state registrations and tonnage fee reports.
  • Review regulatory documentation for accuracy and to ensure quality submissions.
  • Compiles product formula information and routine correspondence reports and other documents as required.

Qualifications  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience       Bachelor of Science degree in food science, animal agriculture, chemistry, biology, or other related field or two year technical degree is required.  Five or more years related experience and/or training or equivalent combination of education and experience.  Legal or regulatory training and /or experience is preferred.

Knowledge, Skills & Abilities 

  • To perform this job successfully, an individual should have the following knowledge, skills and abilities:
  • Strong working knowledge and ability to interpret current domestic (USDA, FDA, AAFCO) and international regulations.
  • Ability to effectively devise and communicate regulatory responses (written and verbal) to peers, customers, and regulatory bodies.
  • Ability to manage multiple tasks while adapting to changing priorities.
  • Detail-oriented with strong organizational and technical writing skills.
  • Proven track record of success working in a regulated environment.
  • Ability to interact daily with a diverse team.
  • Excellent oral and written communication and interpersonal relations skills. 
  • Advanced computer skills in Windows and Internet applications, as well as MS Office applications such as Word, Excel, and Power Point.

#Location: United States

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