Regulatory Affairs Associate Job

REGULATORY AFFAIRS ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in THOUSAND OAKS, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Regulatory Affairs experience
- Experience with JAPAC

WHAT YOU'LL BE DOING:

- Support JAPAC regional regulatory activities
- Provide and maintain CTA/MA documentation support
- Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies
- QC submission-related documents
- Collaborate with local regulatory representatives to support filings and local activities
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- Provide support for drug shipment for JAPAC studies and filings
- Complete regulatory forms to support agency communications
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from local regulatory reps and communicate relevant issues to global teams
- Actively support regulatory compliance
- Support the development and execution of JAPAC goals

WHAT YOU NEED TO BRING TO THE TABLE:

- Master's degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum, OR Bachelor's degree in a science discipline (biology, life science, health science) and 2 years of directly related experience
- JAPAC filings, regulated industry, science or clinical practice experience

GET HIRED, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

TAX TERM: CON_W2J2WSWSCI

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SFSF: LS