Regulatory Affairs Manager Job

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Experience in the preparation of Module 3 (CMC) documents for regulatory submissions
- Excellent communication skills- primarily writing, but verbal as well
- Proficiency in computer skills (Word, EPIC), submission formatting
- Ability to work independently

WHAT YOU'LL BE DOING:

- Support Chemistry Manufacturing and Control Regulatory team in Global Module 3 Authoring Process (GMAP) advancement and life cycle management.
- Coordinate preparation of regulatory Guides, templates and documentation.
- Interfaces with CMC GMAP BPO and GMAP teams and SME, as directed.
- Responsible for coordination of activities related to advancing the status of GMAP Guides, templates, tools and the GMAP Program.
- Responsible for trackers and systems to create documentation of strategy and inputs for life cycle management, as directed.
- Works within Amgen systems for document management and GMAP Program management.

WHAT YOU NEED TO BRING TO THE TABLE:

- Regulatory filing preparation and response to questions experience
- Regulatory CMC and Common Technical Document format experience
- Regulatory strategy experience
- Technical writing and regulatory formatting.
- Manufacture, testing (QA/QC or stability), or distribution in the 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 Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: PROF

MONJOBJ2WPACNW

Ref:

SFSF: LS