Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

State and Local Government Account Executive MA, RI, VT, NH, ME Job Locations US NC Cary HQ | US MA Requisition ID 20060332 Category Sales/Pre Sales Visa Sponsorship No Travel Requirements 50% Location Strong preference for New England or North Carolina based candidate. Nice to meet you! We're the leader in analytics. Through our software and services, we inspire customer

OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu

The Contracts Associate will handle Subsidiary Rights licensing agreements for the various publishers in the Macmillan Trade group of publishers, including Celadon Books, Farrar, Straus & Giroux, Picador, Flatiron Books, Henry Holt & Co., Metropolitan Books, St. Martin's Publishing Group, Tor, and the Macmillan Children's Publishing Group. The Associate will be responsibl

MLTC Dir of Contracts/Compliance Job Locations US NY Bronx ID 2024 4997 Category Regulatory Compliance Position Type Regular Full Time Overview RiverSpring Health Plans serves over 16,000 frail individuals and help them live in their homes and independently for as long as possible. Join our compassionate and dedicated team and make a difference in the lives of our members

The Interoperability Regulations and Standards, Director will work with key external stakeholders to summarize lab related industry standards and regulations and translate any business impact to internal stakeholders. When impactful, this role will be responsible to coordinate internal stakeholders to further assess any impact and help establish solutions. The role will c

Drafting and editing Citi's responses to the Regulatory Consent Orders and related transformation efforts across businesses, functions, and regions, as needed, acting in close collaboration with the Transformation Office, the Transformation Central Legal Team and the CAO Office, among others Strategic thought leadership around effective representations of Citi's work to i

Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus

Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus

DOT is seeking a dynamic City Planner to implement the future of outdoor dining in New York City as a member of the Open Restaurants team. NYC launched the groundbreaking Open Restaurant Program during the height of the COVID 19 emergency to expand outdoor dining options and help restaurants rebound in difficult economic times. The City is now working to turn the emergenc

Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel

CMC Regulatory Strategy Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC projects. Develop solutions to regulatory or business problems where no clear precedence exists. Submissions for Development and Commercial Products Lead activities, including planning and reviewing US CMC sections of all regulatory submissions (i.e.

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state of the art biotechnologies to discover and deliver novel medicines in four disease areas bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments c