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...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Prepare, review, and submit high-quality regulatory documents, ensuring accuracy and compliance with global regulatory requirements. Ensure compliance with regulatory commitments and maintain up-to-date regulatory documentation and databases. Minimum of 8 years of experience in regulatory affairs, w...
Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
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...
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...
You will work closely with the Government Program Manager and Technical Points of Contacts to help execute their program within the defined schedule and budget, work daily with customers to provide status, and insight into program execution. Successful completion of at least one (1) year as Task Ord...
Project manager, program manager, program management, pmp, project management professional, cmc, mst, msat, ms&t, manufacturing, pharmaceuticals, biotechnology, vaccine development, vaccine manufacturing, capital funding, capital funds, gmp, cgmp, good manufacturing practices, sow, statement of work...
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 ...
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...
Senior Associate Regulatory Analyst. Econometrica is looking to hire a part-time Senior Associate with Regulatory and Compliance Subject Matter Expertise within our fast-growing Data and Analytics Group. Other responsibilities will include managing and contributing to research projects, guiding juni...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Data Compliance and Monitoring Specialist. Data Compliance and Monitoring Specialist. The incumbent is responsible for monitoring and reviewing financial transactions/data on an enterprise-wide basis to prevent and detect errors and fraud and to ensure compliance with laws, regulations, policies, an...
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...
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...
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. ...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Currently, we are seeking a Program Manager. Serves as the primary interface and point of contact with Government program authorities on technical and program/project issues. Acts as the overall lead, manager and administrator for the contracted effort. Manages acquisition and employment of program/...
The compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
Lead Construction Projects to Success as a Project Manager at Northeast Contracting Corporation!. Northeast Contracting Corporation is seeking a skilled Project Manager to oversee Commercial Roofing construction projects from start to finish. Project Manager in the Commercial Flat Roofing Industry a...
Responsible for regulatory compliance, regulatory intelligence surveillance and US regulatory licensing. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regul...
The compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
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...
Alternate Program/Contract Manager. The Alaka`ina Foundation Family of Companies (FOCs) has a need for a Alternate Program/Contract Manager to support our government customer located in Silver Spring, MD. Act on behalf of the Program/Contract Manager when not available. Develop and/or Maintain a Pro...