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...
, 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...
closely with Quality, CMC/Regulatory Affairs, Manufacturing, Supply Chain, R&D, Clinical and Corporate Compliance to ensure..., and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate...
, 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...
, and CMC Regulatory Affairs. You will be responsible for: Leading phase appropriate formulation and process development... protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments...
we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials... as a strategic advisor to hiring leaders across scientific, technical, and corporate functions within our U.S. organization...
Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field... existing solutions, while exercising autonomy or applying judgment based on experience to develop new solutions. Lead & create...