Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
This opportunity is located within our AFB International business, the global science and technology leader in pet food palatability.
We develop and produce a full range of liquid and dry palatability enhancers using high-quality ingredients proven to optimize companion animal response and consumption.
Job Description
Summary
The Regulatory Affairs Specialist ensures compliance with all applicable animal feed and pet food regulations related to the import of raw materials and export of finished products.
The Regulatory Affairs Specialist - Import / Export is responsible to provide regulatory guidance on assigned projects, to coordinate the timely preparation and submission of technical information to our customers and regulators in order to ensure timely movement of AFB's US manufactured products around the world.
Essential Duties and Responsibilities
Compiles and coordinates regulatory information for product labels, import / export certificates, questionnaires, and product attributes for use by internal and external customers.
Prepares export certificate documents for international samples and commercial shipments and ensure that templates are set and maintained as export requirements change.
Maintain and updates records relating to international regulations for finished products and raw materials. Reviews product formulas to ensure compliance with applicable domestic and international regulations.
Interacts with various internal and external customers as assigned. Provides regulatory documents in compliance with customer and domestic requirements.
Completes inspection documentation necessary for export approval of our products and develops processes and systems to ensure compliance with export approval programs.
Executes government inspections in a timely manner. Ensures import permits are up to date and that imported product is in compliance with the requirements of import permits.
Fulfills international registration documentation requirements as assigned. Review regulatory documentation for accuracy and to ensure quality submissions.
Compiles product formula information and routine correspondence reports and other documents as required.
Requirements
Required :
Bachelor's Degree in Food Science, Animal Science, Agriculture, Chemistry, Biology, or other related field of study, or equivalent combination of education and experience.
At least 1 year of related experience.
Desired :
Master's Degree in Food Science, Animal Science, Agriculture, Chemistry, Biology, or other related field of study.
2-5 years of related experience.
Knowledge, Skills & Abilities
To perform this job successfully, an individual should have the following knowledge, skills and abilities :
Basic working knowledge and ability to interpret current domestic (based on region) 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 and proficiency with IFS or other ERP software.
AFB International is an Equal Opportunity Employer (EOE). Qualified applicants are considered for employment without regard to race, religion, color, sex, age, disability, sexual orientation, genetic information, national origin, or veteran status.