Act as the Regional Regulatory Lead on products/projects within the assigned therapeutic area. Define regulatory strategy, plans, and objectives. Lead Regulatory Submissions Teams and represent Global TA Regulatory on cross-functional teams. Serve as a Gilead contact for regulatory authorities. Oversee preparation/maintenance of regulatory submissions, labeling, and packaging. Contribute to the development of regulatory strategies and improvements to Regulatory Affairs capabilities. Proactively identify regulatory risks and develop mitigation plans.
Requirements include relevant experience in the biopharma industry and in-depth knowledge of FDA/EMA regulatory requirements.