People Lead overseeing Regulatory Capabilities for Roche's Pharma Development. Collaborating to ensure compliance and drive continuous improvement in regulatory processes.
Responsibilities
Assessing processes, tools, and technology to achieve business goals
Collaborating enterprise-wide to ensure compliance
Partnering with quality organizations across Product Development (PD)
Leading continuous improvement
Overseeing regulations and internal standards
Requirements
Bachelor's degree in Life Sciences, Pharma, Clinical Research or equivalent
7+ years of experience in the pharmaceutical/biotechnology industry
Proven expertise in managing the eCTD lifecycle
Deep understanding of CMC strategy for original submissions
Solid understanding of drug development and GxP/GCP/ICH guidelines
High proficiency in digital tools (Veeva Vault, eCTD software, gSuite)
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