TLL1031 - Regulatory and Document Control Specialist

General Description:  The Regulatory and Document Control Specialist supports with the documentation and compliance of our products; ensures the company is compliant with all applicable internal procedures, regulations and statutory standards; and regulates the control, distribution, retention, and archiving of GMP documents.

Responsibilities:

• Comply and ensure with regulatory permits and/or licenses.
• Assist with regulatory document submissions to Organic, IASC, IFANCA, HALAL, Kosher and other certifying agencies.
• Research and interpret regulations and standards, including USA, European, Chinese, REACH, etc.
• Update and/or develop compliance policies and procedures.
• Responsible for product related surveys; includes global product regulations and standards.
• Manage all regulatory and compliance documents in line with current legislation.
• Support with regulatory inspections and certification audits.
• Create, manage and/or update products Technical Bulletins, Safety Data Sheets, Batch Records, among other documentation and/or statements.
• Create, manage and/or update Standard Operating Procedures, Work Instructions, forms, among others.
• Customer support with the completion / submission of questionnaires, surveys, raw materials forms, statements, etc.
• Prepare special documentation to support a country with product registration needs.
• Assist with Purchase Orders and the creation of Certificate of Analysis.
• Serve as customer consultant to provide service and solutions to inquiries or questions.
• Prepare technical reports, summaries, protocols, and quantitative analysis as required.
• Assist with laboratory analyses, when needed.
• Assist department management with special projects as needed.
• Provide training when needed.
• Travel as required.
• All other duties as assigned.

  Marginal Job Functions:

• Assist with the development and maintenance of spreadsheets and/or tracking tools for measuring department objectives.
• Provides request documents to Inspectors (Regulatory) and/or Auditors (certifiers or customers).
• Provide training when implementing new or revised DOPs and/or forms.

 Education and Qualifications:

• Bachelor’s degree in science or a combination of education and 2 – 4 years of work experience.
• Detailed oriented – accurate, timely work product.
• Ability to multi-task.
• Knowledge of regulatory and compliance matters, like FDA, FSMA, HACCP, FDP, FSVP regulations.
• Knowledge of product principles and theories.
• Excellent analytical skills, and detailed oriented.
• Well developed interpersonal and communication skills.
• Ability to work independently and as part of a team.
• Able to speak, comprehend, read, and write English.
• Ability to effectively communicate with customers and with all levels of the organization.
• Ability to communicate and/or discuss complex regulatory inquiries / issues with customers.
• Knowledge of technical writing, including process writing and document design.
• Computer literacy in Microsoft Office programs and the internet.
• Knowledge of ENSUR Document Management System (a plus).

  Physical Requirements to perform job duties:

• Ability to type and use a computer.
• Ability to see/read details at close range (within a few feet).
• Sit/remain seated for up to 4 hours at a time.
• Verbal communication and auditory skills for effective interactions.
• Ability to walk/move around frequently, especially at customer facilities.
• Ability to remain focused on task to do extensive research.
• Ability to lift up to 15 lbs.