Senior Global Regulatory Affairs Project Manager

<h2><u><b>Purpose</b></u></h2> <p>Support planning, execution and follow-up of timelines and resources for GRA regulatory filings through product development and life-cycle management</p><h2><u><b>Main Responsibilities</b></u></h2> <p><em>Project Coordination</em><br/>- Collaborate with Operational Excellence team members to execute regulatory project coordination and management, including agile ways of working, within GRA utilizing common templates and project plans.<br/>- Support the Therapeutic Areas (TAs) by assisting with the management, and tracking of specific deliverables within GRA, including but not limited to INDs, NDAs, BLAs/MAAs and major variations, working with cross-functional teams.<br/>- Align with Project and Portfolio Management (PPM) to identify key milestones for GRA to meet business objectives, from clinical trial initiation, regulatory submission, approval, and post-approval life cycle management.<br/>- Support internal initiative(s) with a goal to accelerate internal regulatory processes and subsequently development timeline<br/>- In collaboration with the GRA Global Regulatory Leads and/or the GRA Regulatory Managers and Specialists, support the following activities:<br/>  o    Track GRA project related costs to ensure alignment with overall project budgets.<br/>  o    Ensure roles and responsibilities within submission teams are clearly defined.<br/>  o    Cross functional submission team meetings to drive decision making and project execution; help in the creation of agendas, meeting minutes, and tracking/resolution of action items.<br/>- Ensure overall GRA project timelines are aligned cross-TA / cross-functional teams and support the coordination of timely regulatory submissions.<br/>- Identify and recommend solutions for timeline concerns or obstacles, including risks and issues, engaging appropriate leads for mitigation and resolution.<br/>- Coordinate projects which impact more than one TA; setting up and leading cross-TA / cross-functional teams as applicable<br/>- Assist with special projects within Regulatory Operations and Digital as needed.</p><h2><u><b>Experience Required</b></u></h2> <p>5 years in Regulatory with good knowledge of drug development and regulatory procedures</p><h2><u><b>Education</b></u></h2> <p>At least Bachelor’s Degree in Life Sciences</p><h2><u><b>Languages</b></u></h2> <p>Fluency in english </p><h2><u><b>Technical Skills</b></u></h2> <p>Knowledge of regulatory strategy and dossier development, evidence of successful regulatory operations management</p>