/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

Government Relations Manager United States Virtual Req #463 Thursday, December 28, 2023 Want to help people learn the newest ways of working and getting things done? How you'll make a difference You will be responsible for planning, developing and executing a strong positive government relations and advocacy program for PMI. You will be fostering a community relationship

Newport, an Ascensus company, helps employers offer their associates a more secure financial future throughretirement plans,insuranceandconsulting services. Newport offers comprehensive plan solutions and consulting expertise to plan sponsors and the advisors who serve them. As a provider and partner, Newport is independent, experienced, and responsive. Job Summary Assist

Implementation Procurement Associate McKinsey Implementation Who You'll Work With You'll be working with McKinsey Implementation, a rapidly growing capability for our firm, in one of our offices in North America. As a member of MI, you'll work closely with our client project teams, providing end to end support to ensure the clients are able to deliver and sustain the full

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

Braun Medical Inc. ("B.Braun") has an opening for a Senior Counsel, Life Science Regulatory and Quality. The Senior Counsel, Life Science Regulatory and Quality, will support a wide variety of global regulatory and quality matters related to the design, manufacture, distribution and sale of medical devices and pharmaceuticals throughout the world, including product submis

The Specialized Tax Services (STS) Tax Credits & Incentives Senior Associate is responsible for leading or supporting our services to identify, calculate, document, and support on examination by tax authorities Business Incentive Group (BIG) tax credits and other tax incentives. In this role, and utilizing their educational knowledge, experiences, communication, and organ

The Trademark Analyst serves as a subject matter expert internally and externally on all trademark matters related to both verbal and visual branding. This role is responsible for screening both name and logo candidates and clearly articulating rationale to internal and client teams. This role is the cornerstone of our VETT process and must be confident in all steps of th

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

Transportation Security Officers are responsible for providing security and protection of travelers across all transportation sectors in a courteous and professional manner. Their duties may also extend to securing high profile events, important figures and/or anything that includes or impacts our transportation systems. Learn more about the Transportation Security Office

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

Independently implement wide range of data analyses by using R or SAS. Data analyses may include regression analyses, survival analyses, parametric and non parametric testing, data visualization, simulations as well as advanced statistical methods such as propensity score matching, longitudinal data analyses, etc. Lead the drafting of statistical analysis plans and statis

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr