Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The ESOL Program Manager supports the programs and strategic operation of the Adult Education and ESOL department. The ESOL Program Manager oversees student advising, class placement, scheduling, and faculty and adjunct staffing of ESOL courses. This position will work collaboratively across areas t...
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
The Compliance Analyst will also support the LGA Compliance team with regulatory filings, training and L&G Group related deliverables as assigned. The Compliance Analyst is responsible for maintaining producer red flag guidelines and revising these guidelines in partnership with Licensing and Distri...
The Regulatory Affairs Manager, Gene Therapy CDx is located in the United States and will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs and marketing authorization process. This position will also serve as regulatory liaison/legal manufacturer repr...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives. Job Title: Quality Assurance Specialist. We are see...
Quality Assurance Specialist IV. The Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities....
Work closely with Scientific Manager, Directors, and collaborators to manage and provide project support for HPV initiatives. Serve as technical project manager and subject matter expert for subcontracts involving serology and immunology deliverables. Provide scientific and administrative project ma...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
We are seeking a highly motivated Virtual Reality Project Manager to lead our team in the successful. Knowledge of programming and 3D modeling. ...
Construction Project Manager supporting the construction of Automated Vehicle Barrier Systems (AVB). The PM will ensure all projects are delivered in adherence to project scope, schedules, and budget. The PM will communicate with the Contracting Officer Representative (COR), Chenega Program Manager,...
We are seeking a highly motivated, dedicated, and results driven Quality and Regulatory professional to join the team to fill a new leadership role supporting ancillary and cellular starting materials for the development and further manufacture of advanced therapy products in domestic and global mar...
As a Quality Assurance Specialist, you will perform selected quality assurance activities, including reading and understanding SOP’s, complying with cGMPs, writing new standard operating procedures, and supporting the issuance and reconciliation of GMP documentation. Join us at AstraZeneca as a Qual...
Additionally, this position oversees the fiscal unit, ensuringthe budget is accurately programmed, planned, and executed in accordance withthe direction of the Board and applicable laws. Additionally,responsible for budget planning, programming, and execution. ...
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site The Quality Assurance Specialist will ensure compliance with the quality system's proc...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...
Ten (10) years of experience managing programs and contracts of similar scope, type, and complexity as a program or project manager. Program Manager with TS/SCI & PolyID:1912Department:TrainingLocation:MarylandDescription. Senior Program Manager with TS/SCI & Poly. JTG is seeking a Senior Program Ma...
Follow Project Management Framework and corporate processes to complete projects ensuring compliance with all results and project stage gate reviews. The Project Manager will coordinate cross functionally with R&D, Product Management, Marketing, Finance, Planning, QA/QC, Tech Transfer, Engineering, ...
Looking to hire an experienced Project Manager for a MD-based general contractor. Review with superintendent project costs to ensure the project is kept within budget. Potential supervisory responsibilities of an Assistant Project Manager. This is an excellent opportunity to join apany with a proven...
The preferred candidate is a skilled project manager with 9 years of experience managing electrical design projects as prime or a subconsultant to other disciplines. Serve as project or task manager on select projects. Manage a team of engineers, designers, and project managers. Provide input to dev...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
Director of Global Regulatory Affairs - Permanent - Maryland, US. Proclinical is seeking a Director of Global Regulatory Affairs, Development Strategy to lead the U. Director of Global Regulatory Affairs' responsibilities will be:. In this key role, the successful candidate develop and implement reg...
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...
We are seeking a Project Manager to manage growing mRNA based clinical programs. Design, communicate and implement project plans in Smartsheet to ensure projects are completed on time and within budget. Experience with project management tools (MS Project, SmartSheet, etc. Proven project or program ...