What are the responsibilities and job description for the Regulatory and Document Control Specialist position at Terry Laboratories?

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.

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Regulatory and Document Control Specialist

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