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

& 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

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

/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

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

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

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 11 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a

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

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

This is a key leadership position responsible for developing, coordinating, and implementing policies, initiatives, and strategic priorities to advance the county's goals and address key challenges. This role involves collaborating with county leadership and departments, elected officials, community stakeholders, and external partners to drive policy development, facilita

Analytics Advisory Associate Manager, L8 Location Burlington, NJ Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services creating tangible value at speed and scale. We are a talent an

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

/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

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

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