ful travel based on client and business needs. Expect 30 50% travel What We Offer At BCG, we care about our people, and offer best in class benefits to support you personally and professionally throughout your different life experiences including An opportunity to work organically across disciplines and across BCG, we offer a unified and unrivaled opportunity that combines

Since 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innovations. It serves as inspiration and foundation for our future success. We're proud to be stewards of amazing brands that people trust. We foster a culture of belonging where people come first, and diversity is embraced. And we live our values, always, w

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

& Essential Functions include Data Integration and Analysis. Supporting various data integration efforts by performing data entry, editing, and/or validation tasks. Maintaining integrity related databases and tracking tools. Providing data maintenance support as directed by, and with oversight from, Integrity department staff. Performing basic data analytics and visualizat

ful travel based on client and business needs. Expect 30 50% travel What We Offer At BCG, we care about our people, and offer best in class benefits to support you personally and professionally throughout your different life experiences including An opportunity to work organically across disciplines and across BCG, we offer a unified and unrivaled opportunity that combines

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

Cash Analysis, Investment Strategies, Debt Management, Treasury, Municipal Debt, Bond issue

/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

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

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

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

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

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

t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger