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Associate Director of Regulatory Affairs CMC

Real Staffing is looking for an Associate Director of Regulatory CMC for a biotechnology company in Southern California

Company: A biotechnology company developing therapies for cancer and other diseases.

Role:

As an Associate Director of Regulatory Affairs CMC you will be responsible for providing CMC regulatory leadership and strategy required to achieve regulatory approvals. This includes: providing input for regulatory submissions, managing completion and review and presenting CMC sections of regulatory documents

Requirements:

-Over 8 years of experience in the pharmaceutical or biotech industry directly in regulatory affairs.

- Strong knowledge of regulatory requirements

- Strong Project Management skills and ability to motivate colleagues

-Advanced knowledge of pharmaceutical development, biostatistics, clinical research and medical terminology

-Advanced technical experience in software tools

- Ability to be a decision maker

Salary:

Competitive Market Salary + Excellent benefits package

If you are interested in hearing more about this opportunity, please directly apply to this advertisement

Sthree US is acting as an Employment Agency in relation to this vacancy.