The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, re...
Regulatory Affairs Manager in the Gaithersburg, MD area. As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. The RAM contributes to regulatory submission strategy, ide...
Regulatory Affairs Manager - (MGRRA_COMPANY_1). Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure com...
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy. Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory stra...
Manager, Regulatory Affairs Advertising & Promotion - Remote. Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment update...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vi...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, re...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regula...
Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients.USP's fundamental belief that Equity = Excellence manifests in our c...
The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulato...
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy. Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory stra...
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 and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
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 Director, Regulat...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
The Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Assist the Project Manager and Supe...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Civics Education Project is a dynamic and passionate consulting firm dedicated to creating positive change in our community. As a Paid Canvass Manager, you will play a key role in mobilizing our supporters and engaging with voters to promote our campaign's message. ...
Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
As a Comfort Advisor, also called Project Manager- Outside Sales, you will assist our clients with their heating and cooling needs and present solutions to make their personal space more comfortable. Whether you're interested in becoming a Field/Department Manager or maybe you're interested ...
As a Cybersecurity Compliance Manager. You will support the Chief Information Security Officer (CISO), the Chief of Classified IT Compliance and the Principal Organizational Information System Security Manager (ISSM) in carrying out the Laboratory 's Classified Information Security Program. You will...
HIAS seeks a Budget & Fiscal Compliance Specialist, North America to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas. Manages reporting, complianc...