Regulatory Affairs Specialist 2 Job at Arbonne, Irvine, CA

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  • Arbonne
  • Irvine, CA

Job Description

PURPOSE:
The position of Regulatory Specialist II in Nutrition reports to the Sr. Manager and will work closely with R&D and Marketing. This position will entail ensuring the compliance of nutritional products in the countries that Arbonne does business in. These will include performing ingredient assessments, research as needed for claims substantiation. It will also include the review of labels and marketing material and be knowledgeable in product licensing activities such as premarket approvals required (Canada Natural Health Products, Australia TGA, etc.) and notifications (US FDA, EU) and any market expansion. Assist the nutrition team and management by giving updates and assessments on nutrition projects. Provide timely feedback to inquiries made to help support the cross-functional teams.

DUTIES AND RESPONSIBILITIES:
  • Lead the label creation and review process according to SOP 08-001, for the countries that Arbonne does business in
  • Perform ingredient reviews to ensure product compliance using the Health Canada NNHPID database, TGA Listed Complementary Medicines database and be familiar with EU Directives for Foods and Food Supplements, and other country databases as appropriate.
  • Review and validate the evidence of support and other articles of substantiation for product claims as provided by R&D.
  • Prepare notifications (US FDA, EU).
  • Review marketing collaterals in all the countries that Arbonne does business in.
  • Provide timely responses to inquiries as needed to ensure regulatory compliance.
Responsible for the periodic file maintenance of regulatory nutrition documents.
  • Prepares and submits periodic reports, as required and performs special tasks and assignments, as required.
JOB REQUIREMENTS:

Education:

Minimum qualifications:
  • Bachelor's Degree (BS) Food Science and Nutrition.
Preferred qualifications:
  • Prefer Master of Science (MS) in Food Science and Nutrition.
Experience:
  • 3+ years experience in nutritional regulatory will be required, but a Master's Degree
will fulfill some of this requirement for an entry level position.

Functional/Technical
Knowledge, Skills
and Abilities Required:

  • Good understanding of US Food regulations; knowledge of other markets - a plus
  • Technical writing skills; high accuracy on document preparation and review
  • Proficient computer skills (Excel, Word, PowerPoint)
  • Detail oriented, able to work with spreadsheets and data collection
  • High level observation skills, work with little or no supervision
  • Excellent communication skills, both oral and written
  • Ability to multi-task and prioritize work
  • Research Skills

Here is the legal stuff: Requirements:

Type ONE 'X' for each Activity to indicate the appropriate Physical Requirements:

ACTIVITIES

ESSENTIAL FUNCTIONS

ESSENTIAL FUNCTIONS

ESSENTIAL FUNCTIONS

Mobility

x
  1. Frequent sitting
  2. Limited standing, walking, climbing, crouching, bending, pushing, or pulling
  1. Occasional sitting
  2. Occasional standing, walking, climbing, crouching, bending, pushing, or pulling
  1. Limited sitting
  2. Frequent standing, walking, climbing, crouching, bending, pushing, or pulling
Travel

x
  1. Limited travel or overnight
  1. Occasional travel or overnight
  1. Frequent travel or overnight; including international
Visual/Hearing

x
  1. Normal or corrected vision and hearing
  1. Normal or corrected vision and hearing
  2. Not colorblind
  1. Normal or corrected vision and hearing
  2. Not colorblind
  3. Can distinguish varying or specific colors, patterns or materials
Language
  1. Understand, speak, read and write basic English
x
  1. Understand, speak, read, and write fluent English
  1. Understand, speak, read and write fluent English
  2. Understand, speak, read and write fluently in a foreign language

Physical Activity

x
  1. Lift approximately 0-25 lbs.
  2. Use of fine motor hand functions
  1. Lift approximately 25-50 lbs.
  2. Use of fine motor hand functions
  1. Lift approximately 50+ lbs.
  2. Use of fine motor hand functions
Environment

x
  1. Typically indoors
  2. Typically in a consistent temperature
  1. Occasionally outdoors
  2. Occasionally exposed to varying degrees of hot and cold environments
  1. Frequently outdoors
  2. Frequently exposed to varying temperatures from below 32 degrees to above 80 degrees

Arbonne International is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sexual orientation, national origin/ancestry, age, sexual orientation, gender identity, gender expression, military/veteran status, marital status, disability status or any other basis prohibited by law. At Arbonne International it's about each person bringing passion and skills to a dynamic and inclusive workplace!

Job Tags

Night shift,

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