Regulatory Affairs Associate Job

SENIOR 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 experiences

WHAT YOU'LL BE DOING:

- Support Chemistry Manufacturing and Control Regulatory staff performing product development and life cycle management.
- Coordinate preparation of regulatory filings and amendments.
- Interfaces with Operations, various product teams, various site teams, regional teams and other contract services as directed.
- This position is responsible for preparing facility registration documents and country specific documents to be utilized in regional submissions.
- Works within Client's systems for document management and change control management.

WHAT YOU NEED TO BRING TO THE TABLE:

- Computer skills-EPIC/DECADE/TRACKWISE/EDM is a plus Regulatory background-college experience-1 - 2 years
- Really need someone who has regulatory computer work-the programs listed above
- Background and degree/certification would be extremely helpful
- Document management system experience
- Change control management system experience.
- Common Technical Document format experience.
- Technical writing and regulatory formatting.
- Manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry.
- Commercialization or marketing application experience.
- Strong interpersonal skills.
- Excellent communication (both written and verbal), presentation and facilitation skills.
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity.
- Strong computer skills, including word processing, database and project management software.
- Strong team player with a commitment to customer service.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelor's degree and two (2) years Regulatory or Regulatory CMC experience OR
- Associate's degree and six (6) years Regulatory or Regulatory CMC experience OR
- High school diploma/GED and 8 years Regulatory or Regulatory CMC experience

RECRUITER: Mary Nguyen

Yoh, a DayJ2W: CLINICAL

MONJOB J2WSWSCI

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SFSF: LS