CMC Regulatory Manager Job

CMC REGULATORY MANAGER needed for a CONTRACT opportunity with Yoh's client located in KING OF PRUSSIA, PA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- CMC Regulatory
- FDA requirements

WHAT YOU'LL BE DOING:

- The scope of the work is to manage the CMC (Chemistry, Manufacturing & Controls) aspects of one or more development and/or approved vaccine products.

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of a bachelors degree in a scientific discipline plus three (3) or more years of CMC experience with for FDA-regulated biologics (small molecule experience will also be considered).
- Understanding of US regulations and regulatory expectations for biologics.
- Understanding of biologics manufacturing and analytical methods.
- Background in a functional discipline related to biologics CMC a plus (cell banking, upstream or downstream operations, secondary manufacturing, validation, analytical testing, etc)
- Experience interacting with regulatory agencies, preferably FDA
- Experience assessing the regulatory impact of changes to biologic product manufacturing & testing process/procedures for marketed products
- Experience in the critical review of submissions for content, quality and compliance
- Experience with technical writing of CMC documents

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a DayCLINICAL

TAXTERM: CON_W2

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