Vice President, Regulatory Operational Excellence

April 6

Intel Corporation

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Intel’s mission is to shape the future of technology to help create a better future for the entire world$1. .$1

semiconductor design and manufacturing • artificial intelligence • autonomous driving • non-volatile memory solutions

10,000+

Description

• Oversee multiple regulatory groups including Regulatory Operations, Regulatory Business Operations, and Medical Writing • Manage personnel and budget within Regulatory Affairs department • Drive operational transformation to accommodate corporate objectives • Develop and rollout document templates and writing standards • Ensure compliance with regulations, GxP standards, and guidelines • Serve as a conduit of information flow between Regulatory leadership and functions

Requirements

• Bachelor’s degree in a scientific discipline required; advanced degree highly desired • Minimum 12-15 years regulatory industry experience in biopharmaceuticals • Experience with Veeva and implementation of new processes within Veeva • Management of a budget and fiscal planning experience • Hands-on or oversight experience with regulatory support of clinical trials • Experience with BLA/MAA and post-marketing strongly preferred

Benefits

• Enable normal lives for patients with autoimmune diseases • Lead asset, IMVT-1401, a novel anti-FcRn monoclonal antibody in clinical development • Develop and deliver high-value restorative therapies for autoimmune diseases • Opportunity to serve as a leader in regulatory affairs operational excellence • Work with a dynamic team committed to transforming patient care