Senior Associate Regulatory Affairs Job

SENIOR ASSOCIATE REGULATORY AFFAIRS needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.

What You'll Be Doing:

- Coordinate preparation of regulatory filings and amendments.
- Interfaces with Operations, various product teams, various site teams, regional teams and other contract services as directed.
- Responsible for coordination of site-specific change control regulatory
- Support Chemistry Manufacturing and Control Regulatory staff performing product development and life cycle management.
- Assessments with input from the CMC Product teams and the CMC Region representative.
- Works within Amgen systems for document management and change control management,

What You Need to Bring to the Table:

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

Bonus Points! Otherwise Known As Preferred Qualifications:

- 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.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOB J2WSWSCI

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