CMC Regulatory Affairs Associate Job

CMC REGULATORY AFFAIRS MANAGER needed for a CONTRACT opportunity with Yoh's client located in King of Prussia, PA area.

WHAT YOU'LL BE DOING:

- The scope of the work is to partner with CMC Regulatory Affairs personnel by reviewing historical CMC registered files (BLAs/supplements/amendments) and authoring/compiling compliant CTD formatted documents within project timelines and with limited oversight.
- Technical writing of CMC documents
- Critical review of submissions for content, quality and compliance

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of a Bachelor's 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 in the critical review of submissions for content, quality and compliance
- Experience with technical writing of CMC documents
- Experience with Documentum and the aptitude to learn various IT systems as they relate to training, document creation, formatting, publishing activities, etc.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: SCIENTIFIC

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