Senior Associate Regulatory Affairs Job

SR 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 Site Manufacturing experience, document editing/management, and project management

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 company's systems for document management and change control management,

WHAT YOU NEED TO BRING TO THE TABLE:

- Document management system experience
- Change control management system experience.
- Common Technical Document format experience.
- Technical writing and regulatory formatting.
- Project Management
- 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 eight (8) years Regulatory or Regulatory CMC experience

RECRUITER: Mary Nguyen

Yoh, a DayJ2W: PROF; MONJOB

TAX TERM: CON_W2J2WBRLA

Ref:

SFSF: LS