to ensure corporate and health authority deadlines are met. Management of submissions archives and correspondence. Serve...-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance. Skills...
, you will be at the forefront of transforming groundbreaking scientific discoveries into accessible and impactful healthcare solutions... (PSI) department. Its mission is to shape Roche’s pipeline, improve the portfolio, anticipate needs, and deploy solutions...
Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field... and complexity, generally applying existing solutions, while exercising autonomy or applying judgment based on experience to develop...
Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field... and complexity, generally applying existing solutions, while exercising autonomy or applying judgment based on experience to develop...
which covers five main areas, Regulatory Strategy, Regulatory CMC, Regulatory Operations, Regulatory Intelligence, and Regulatory... and accountable for delivering Regulatory Strategy and Operational excellence, that is aligned with Akebia’s overall corporate...
80 CMC Forest, Forest, MS, 39074 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status... of automation solutions and advanced IIoT / Industry 4.0 technologies in support of manufacturing. The role includes developing...
which covers five main areas, Regulatory Strategy, Regulatory CMC, Regulatory Operations, Regulatory Intelligence, and Regulatory... and accountable for delivering Regulatory Strategy and Operational excellence, that is aligned with Akebia’s overall corporate...
, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs... as understand the multi-functional implication of project activities and decisions on project and corporate objectives. Makes...
audience. Can represent CMC viewpoint at corporate and industry level. Resource Management - ability to anticipate and manage... to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership: Provides strategic scientific...
, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate... across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health...