Associate Regulatory Affairs Job

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Regulatory experience
- Someone who speaks an Asian language
- Pharma background

WHAT YOU'LL BE DOING:

- Assist Regional Regulatory Lead to support regional regulatory activities
- Provide and maintain CTA/MA documentation support in collaboration with Regional Regulatory Lead
- 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
- Support RRL in QCing 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 (eg Eudract, FDA form 1571)
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to RRL
- Actively support regulatory compliance
- Support the development and execution of JAPAC goals

WHAT YOU NEED TO BRING TO THE TABLE:

- Strong communication skills - oral and written
- Strong organizational skills
- Attention to detail is a must
- 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)
- Two (2) years of directly related experience

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Regulated industry, science or clinical practice experience

RECRUITER:Mary Nguyen

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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