Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

Ensure the development of appropriate regulatory strategy(ies) and their execution for for early and/or late stage HIV or other assigned asset(s) consistent with Medicines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy

To effectively perform all the required duties of the Corporate Graphics and Labeling Manager position in an accurate, thorough, and safe manner for CBC, CBQ, OWS, as outlined per the Carl Buddig and Company job description. Work Environment Must be able to work in various temperatures (office/lab/production). Must be flexible and able to work as needed. Must be able to w

/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

Contract Support Specialist (CSS) Job Locations US FL Tampa ID 2024 4982 Category Construction Mgmt and Inspection Type Full Time Regular 40 hours Posted Date 39 minutes ago (1/4/2024 4 33 PM) Overview Join us as we Rise to the Challenge At KCI, we're building an enduring community that provides unparalleled value to our employee owners. We make our mark designing and del

Coordination of documentation and volumes tendered to the OCFO (Own Control Flight Operations) Preparation & processing of MAWBs Effective follow up of pending bookings Confirmation of flight departures Close communication with Regional and Global OCFO, Gateways, GHAs and other internal as well as external stakeholders Coordination and following of any and all government

The Director, Regulatory Affairs for EMEA is responsible for successful completion of complex regulatory projects, including pre submissions and IDE submissions to FDA, IRB submissions, Ethics Committee submissions, EU Annex XIV submissions and as well as premarket authorization applications, including PMAs and EU Technical Documentation submissions to the notified body a

Management and Engineering Technologies International Inc., in support of the U.S. Forest Service International Programs (hereinafter “USFS IP”) may seek the services of a Program Coordinator in Gabon to work with national governments as well as local, national and regional organizations in the Congo Basin region to provide technical assistance on sustainable

Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi Global Rare Disease products in the United States. This position is also responsible for providing input to risk management activities, managing the labeling control process, including generation of new labeling and changes to existing labeling, and submission of l

of Role Responsible for integrating and applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned preclinical and/or clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all

The Translational Science and Precision Diagnostics (TSPDx) Regulatory Science team at QIAGEN fulfills a global function, working with and advising Companion Diagnostic (CDx) and other product development teams, developing and delivering competitive and innovative regulatory strategies, preparing regulatory submissions for the relevant countries, and supporting change con

Aquatics Aquatic Program Supervisor Pool & Beach Pay Rate $23.59 $28.17 The City of Kirkland is hiring for the Peter Kirk Pool and Kirkland's three swimming beaches. We are looking for Aquatic Program Supervisor (APS) for our pool and swimming beaches this upcoming 2023 Summer Season. Please see details on the position below. An APS supervises all aquatics programs and st

Overview Assessment Clerk Beckett Springs is a 96 bed behavioral hospital located West Chester, OH. The hospital offers inpatient and outpatient mental health and addiction treatment to adults, adolescents and their families. At Beckett Springs we are dedicated to Changing People's Lives Members of our team enjoy Working with a highly engaged staff Healthy staffing levels

Review and respond to submissions in the SDS request form, collaborating with team leads for effective problem solving. Submit SDS changes and Finished Good requests using the 3E ERD portal. Download/upload new SDS from the 3E portal and seamlessly integrate them into the company's storage environment. Work closely with Formulations consultant to populate 3E Protect syste

Management and Engineering Technologies International, Inc. (METI), in support of the U.S. Forest Service (USFS) Office of International Programs, may require the services of a Democratic Republic of the Congo (DRC) Africa Climate Fellow to advance climate ambition in DRC and the broader Central Africa Region through the provision of technical assistance in the areas of c