Company Description Are you ready to trade your job for a journey? Become a FlyMate! Passion, excitement & global... where they are in the world. What more do we need to truly be unstoppable? Perhaps, that is you! Who we are: Flywire is a global...
of regulatory strategies in alignment with GRD CMC-RA Head and Small Molecule Portfolio Lead for assigned projects, which may... on Regulatory CMC Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory...
as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory... to get involved in the global regulatory strategies and support the research, development and commercialization...
changing regulatory landscape as well as understanding the requirements as Vertex moves into new global markets. The role... and implement global regulatory expectations Establish cross-functional working groups, including SMEs, to facilitate review...
successful candidate will be responsible for developing and implementing regulatory strategies to support the global development..., Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents. Lead and manage FDA...
approvals in the US market. Expert knowledge of clinical development within US and Global regulatory strategy. Support..., we are seeking a US RA Manager to join our Quality and Regulatory Affairs team. Missions Provide management and leadership to the...
approvals in the US market. Expert knowledge of clinical development within US and Global regulatory strategy. Support... a US RA Manager to join our Quality and Regulatory Affairs team. Missions Provide management and leadership to the...
an experienced Director/Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support... Director, Regulatory Affairs will work closely with the FOTIVDA Project Lead, Marketing team and Commercial organization...
and implementation of innovative global/regional regulatory strategies for new product development within the Vertex portfolio... to post marketing application stage) outlined in Global Regulatory Strategy Documents supporting the Pain portfolio products...
global client engagement agenda Work with the Global Regulatory Lead and Product to plan and execute the transition... to evolving regulations and influencing the global regulatory framework that supports our products. You will act as a senior...
: Lead multiple teams of Regulatory Administration and Filings staff that provide clients with board administration services... and regulatory filings to the SEC. Lead delivery of prospectuses, proxy statements, and other SEC required filings to clients...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the.... This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements...
Executive Director, Regulatory Affairs, and will be responsible for contributing and delivering global regulatory strategies... for various departments, projects, and teams. Key Responsibilities: Develop and implement global regulatory strategies...
, you will be responsible for ensuring our customers' success with Veeva's regulatory products and services. You will serve as the liaison..., and working cross-functionally to improve the overall customer experience. What You'll Do Support 4-6 large, global customers...
Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for assigned products... team Contributes to and may lead global regulatory strategy development for certain programs Responsible for regulatory...
About Ropes & Gray: Ropes & Gray is a preeminent, global law firm. The firm has been ranked in the top-three on The... support in the implementation of the Health Care (HC) & Life Sciences Regulatory & Compliance (LSRC) practice groups...
, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific... content, lead the team through meeting rehearsals and moderate the meeting itself. Lead a Global Regulatory Strategy Team...
and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing...: Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator...
Responsibilities: Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure... to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects...
Our client is a leading global life science consulting firm specializing in helping pharmaceutical, biotechnology...-functional teams to develop customized solutions and proposals for clients. Manage the entire sales process, from lead...