Regulatory Affairs Document Specialist

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Job description

Regulatory Affairs Document Specialist

Well established and growing nutraceutical company is growing their team and adding to their Regulatory Affairs department!

This person will be supporting the Latin America regions so we need someone who is bilingual Spanish (verbal and written communication).

Summary:

The Regulatory Affairs Document Specialist provides support in various projects, including formulas, labels, product materials, and records review, product registration and help support the work associated with obtaining government approval for product imports into global markets. The key scope of this job is to deliver support in order to ensure effectiveness, efficiency, and accuracy of daily operations in Regulatory Affairs team. This position will work cross functionally with Research & Development, Purchasing, Marketing, Quality and other departments.

ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS:

Creates, revises, and maintains records of US master labels and basic registration documents including but not limited to Manufacturing Process, Nutritional Information, Product Formula, Product Safety Statement, Technical Data Sheet, Technical Info on Key Ingredients.
Prepares documents, communicates, and maintains record keeping for product registration renewals for applicable countries.
Requests from suppliers and maintains up-to-date raw material documents including allergens, gluten, GMO, Kosher/Halal, etc.
Performs and manages country legalizations tasks including requesting money, contacting courier, placing request for embassy legalizations, mailing and tracking documents, etc.
Assists in the management of project timelines and provides support to project teams and Senior Management.
Reviews and ensures compliance and technical accuracy with formulation, label graphics, and ingredient claims.
Maintains accurate and up-to-date regulatory records and databases and responds to document and information requests.
Requests samples as needed.
Assists with process development.
Handles basic issues and problems and refer more complex issues to higher-level staff.
All other duties as assigned.

EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:

Minimum education: Bachelor's degree or equivalent work experience. Preferred: Bachelor of scientific or health discipline.
Minimum experience: 0-1 year of experience of Regulatory Affairs in food, dietary supplements, cosmetics, medical device, pharmaceutical or related field. Preferred: 1-2 years of experience in Regulatory Affairs in food, dietary supplements, cosmetics, medical device pharmaceutical or related field. Project Management experience.

Apply today for immediate consideration to:

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice