Jobs via Dice ยท 1 day ago
Regulatory Affairs Document Specialist
Scottsdale, AZ
Full-time
Onsite
New Grad, Entry Level
0+ years expApex Systems is a world-class IT services company seeking a Regulatory Affairs Document Specialist to support their growing team in the nutraceutical sector. The role involves managing product documentation, ensuring compliance, and working cross-functionally with various departments to facilitate product registration and approvals.
Computer Software
Responsibilities
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
Qualification
Required
Bachelor's degree or equivalent work experience
0-1 year of experience of Regulatory Affairs in food, dietary supplements, cosmetics, medical device, pharmaceutical or related field
Preferred
Bachelor of scientific or health discipline
1-2 years of experience in Regulatory Affairs in food, dietary supplements, cosmetics, medical device pharmaceutical or related field
Project Management experience
Benefits
Medical
Dental
Vision
Life
Disability
Other insurance plans
ESPP (employee stock purchase program)
401K program
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
Corporate discount savings program
Discounts
On-demand training program
Access to certification prep
Library of technical and leadership courses/books/seminars
Certification discounts
Perks to associations that include CompTIA and IIBA
Dedicated customer service team for our Consultants
Certified Career Coach
Company
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