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Regulatory Affairs Specialist II, Irvine, CA

Kelly Services

Irvine, CA
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Regulatory Affairs Specialist II, Irvine, CA

Jobid US15TPAC_BH1425969

Location: Irvine, CA, 92604, USA

Description **Regulatory Affairs Specialist II - Personal Care Products, Irvine, CA**

Seeking an experienced Regulatory Affairs Specialist looking to expand their knowledge of international markets, and possessing expertise in personal care products.

As a Regulatory Affairs Specialist, you will insure global regulatory compliance of products throughout the product development cycle including general Cosmetics, OTC Monograph drugs, and Nutritional products, and monitor global regulatory developments potentially affecting the business.

**Job Duties and Responsibilities:**

+ Manage assigned product brands in line with Product Development/Marketing Brand Managers
+ Review and approve formulas, raw materials and other product design criteria
+ Assist in preparing and maintaining domestic and international product registrations, regulatory filings and notifications within launch timetable. Track regulatory submissions and approvals for shipment releases. Communicate status and results to cross functional teams during category meetings.
+ Maintain up-to-date product notification and registrations, including registration expirations, discontinuances or product changes for cosmetics and cosmeceuticals
+ Review product changes to determine impact to existing labeling or registration; provide Regulatory input to change control requests
+ Assist in review and approval of package label to ensure all country labeling requirements are met
+ Assist with collateral development and other marketing material, as well as review and release
+ Compile up-to-date product EU technical dossiers, as needed. Work closely with respective internal departments to obtain all necessary documentation to achieve completion
+ Provide technical Regulatory representation to cross-functional teams, with emphasis on product launch planning and execution
+ Assist Sr. Manager with Standard Operating Procedures for routine Regulatory transactions and work processes
+ Prepares and submits periodic reports, as required and performs special tasks and assignments, as required
+ Create and implement strategies with Sr. Manager or with multi-functional teams for international regulatory submissions
+ Stays current on global regulatory requirements for personal care and pro-actively communicate these requirements within the organization
+ Creates and applies documentation and control systems as required for regulatory areas
**Job Requirements:**

+ Bachelor's Degree (BS) in Chemistry, Food Science or Molecular Biology preferred
+ Successful candidate must have at least 1 year in Cosmetics and/or Nutrition related Regulatory work
+ Requires a comprehensive working knowledge of FDA regulations as well as foreign country product regulations (Canada, Australia, EU, Asian Pacific markets) relative to personal care
+ Must be proficient in Microsoft Word, Excel, Outlook and PowerPoint
+ Knowledge of, but not limited to PCPC (formerly CTFA), TGA, AUS NICNAS, New Zealand Product Group Standards, Cosmetics Europe (formula EU Colipa), Canada NPN, TMAL and Specialty Foods, Australia Listed Medicine, Australia/New Zealand Food Standards Code, EU Food Law, US DSHEA
+ Excellent communication skills, both oral and written
+ Attention to details, work with less supervision, and able to keep up with deadlines
+ Ability to multi-task and still able to set priorities
**For immediate consideration, apply today! Questions? Call Airika at 562-206-2707**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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