Regulatory Affairs Associate II - IND Readiness
BioSpace
Leidos Biomedical Research, Inc., Rockville-based, is seeking a Regulatory Affairs Associate to support IND filing readiness and regulatory submissions for translational programs in NCATS collaborations. You will coordinate, write, review, and finalize regulatory documents, manage timelines, and ensure compliance across FDA, Health Canada, and EMA with CROs and NIH partners. The role emphasizes document control, version tracking, and proactive issue resolution in a fast-paced, cross-functional #J-18808-Ljbffr BioSpace
$69.8k - $100.05k
...efforts include preclinical and IND-enabling development... ...supports efficient preparation of regulatory materials and documentation... ...The Regulatory Affairs Associate will support regulatory strategy... ...operations to ensure IND filing readiness for translational programs,...SuggestedFull timeContract workPart timeFor contractorsWork at office$140k - $160k
...Program Manager II Department ATCC Federal Solutions Role Type onsite Category... ...Biorepository, Biotechnology, Cell Biology, Cryobiology, Regulatory Science Overview Ready to shape the future of science and global health? A global...SuggestedContract workTemporary work$71k - $90k
...the information well-organized and in a state of inspectional readiness, maintaining record integrity and security, and retrieving and... ...company's facility. This activity is essential for maintaining regulatory compliance and preparing for pre-approval and general...SuggestedWork at officeVisa sponsorshipFlexible hours- ...guidance. The role involves inspecting GMP facilities, participating in internal audits, and ensuring record integrity and inspection readiness. Responsibilities include review of GMP docs, line clearances, audits of suppliers, and assisting FDA inspections. #J-18808-...Suggested
- ...Actuarial Analyst II - Large Group Pricing This individual contributor is primarily responsible for providing support for researching... ...on standards, assumptions, competition, and the legal and regulatory environment. Analyzes financial risks and opportunities by applying...SuggestedTemporary workWork experience placement
$19.08 - $21.84 per hour
...and Shepherdsville, KY. As an Adventure Readiness Specialist, you are a critical part of the... ...with our recruiting system; (ii) carrying out, analyzing and improving our... ...with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v)...Hourly payFull timeContract workTemporary workPart timeSeasonal workLocal areaFlexible hoursShift work$87.72k - $142.25k
...impact at EagleBank. As a Project Manager II , you will lead high-visibility, cross-... ...transformation, operational excellence, regulatory priorities, and long-term growth strategy... ...configuration, testing, defect resolution, data readiness, implementation, training, deployment,...Contract workFlexible hours- Supernus Pharmaceuticals is a biopharmaceutical company with 30+ years of CNS disease experience, currently offering a Quality Assurance & Compliance role in Rockville, MD. The position focuses on initiating and reviewing documentation, ensuring CFR/FDA alignment, and supporting...
$67.5k - $110k
...is seeking a Project Manager II to support the Murtha Cancer... ..., the Department of Veterans Affairs, and the DoD. The first study... ...protocols and preparation of regulatory submissions to Institutional... ...quality management and regulatory readiness including coordinating...For contractorsWork at office$75k - $95k
...planning, environmental consulting, and regulatory coordination for large-scale infrastructure... ...is seeking a full-time Project Manager II to join our Commercial Permitting team. The... ...Required Qualifications Education: Associate degree or equivalent combination of education...Full timeFor contractorsWork at officeLocal areaRemote workFlexible hours- ...Job Description Under general supervision of a more senior project manager (e.g., PM III, PM IV, PMO Lead), the Project Manager II oversees multiple projects or one larger project. The Project Manager II implement(s) JBS project management best practices in one or...Contract workTemporary workFor subcontractorWork at officeRemote work
$59.4k - $89.1k
...environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As a Client Services Project Manager II at Thermo Fisher Scientific's Clinical Trials Division, you will contribute to ensuring successful delivery of clinical trial projects...Full timeTemporary work$66k - $99k
...and laboratory functions on site. As a Quality Specialist II , you will play a highly visible, client-facing role within the... ...documentation in accordance with applicable procedures. Review protocols associated with qualification and validation of temperature-controlled...Full timeTemporary workWork at officeMonday to FridayRotating shift- ...Records Management Specialist II Employment Type: Full-Time, Mid-Level CGS is seeking an experienced Records Management Specialist to provide administrative support for a large Federal agency initiative. CGS brings motivated, highly skilled, and creative people...Full timeWork at officeFlexible hours
- ...fields. Possession of one of the following active security certifications: CGRC, CASP+ CE, CISM, CISSP (or Associate), GSLC, CCISO - (minimum DoD 8570 IAM Level II Certification). Proficiency in Risk Management Framework (RMF). Active TS/SCI + Polygraph clearance....Full time
- ...and Innovation. POSITION SUMMARY: The Operations Specialist II, also referred to as the Virginia Newspaper Liaison, is a hybrid... ...is responsible for the review and management of all functions associated with our newspaper vendors. The Specialist will correspond with...Full timeWork at officeLocal areaRemote workFlexible hours
- ...partnership with Engineering and Product. As a Data Intelligence Analyst II, you will collect, analyze, enrich, and integrate data to help... ...Qualifications Bachelor's or master's degree in international affairs, data science, computer science, intelligence studies, Chinese...InternshipWork at officeFlexible hours
- ...Advancement of Military Medicine, Inc. seeks a Project Manager II to support the Murtha Cancer Center Research Program in... ...investigators, CRCs, and statisticians, developing SOPs, staying regulatory-ready, and preparing monthly reports for MCCRP leadership. #J-18808...
- Rivian is seeking an Adventure Readiness Specialist to support the Service team during peak seasonal periods at locations including Gaithersburg, MD. You will help prepare vehicles, maintain a clean and safe service center, and assist with basic repairs under supervision...Seasonal work
$72.57k - $104.29k
...certified fleet staff. WHO WE ARE LOOKING FOR The Department of General Services, Fleet Management Services is seeking a Program Specialist II for the Training/Quality Assurance Team at the Division of Fleet Management Services. This position provides administrative and...Shift work- ...Description Job Description SUMMARY The Financial Advisor II is primarily responsible for supporting the senior financial... ...Advisor II regularly works in conjunction with the client service associates to ensure proper preparation and completion of documentation for...
- HMSHost is seeking an HRIS Analyst II in Bethesda, MD to maintain HRIS and payroll data integrity, optimize integrations, and support HR and Payroll teams. The role emphasizes accuracy, data quality, and collaboration with IT to resolve issues. It requires 5+ years in...
- ...centers, seeks a Senior Accounting Manager/Senior Technical Accountant in Rockville, MD. The role combines technical accounting with readiness for a potential public transaction and close efficiency improvements. You will partner with auditors, legal, and finance teams to...
$102k - $118k
Senior Regulatory Analyst (HS/IRB) (Part-Time) Ripple Effect United States Senior Finance... ...transparency, quality assurance, and audit readiness. Quality Management : Ensures... ...sciences, biomedical sciences, regulatory affairs, law, public administration, or a related...Hourly payFull timePart timeWork at officeLocal areaRemote workFlexible hours- ...Assurance Specialist to support GMP compliance across documentation review, facility inspections, and audit readiness within CNS drug development. The role emphasizes regulatory alignment with CFR/FDA guidance and readiness for upcoming inspections. The ideal candidate has a...
$101.4k - $154.7k
This position is responsible for the overall planning, execution, and reporting of a portfolio of projects and programs; overseeing the dependencies between interconnected projects and managing portfolio-level plans to achieve strategic objectives. The incumbent will manage...Temporary workWork experience placementWork at officeFlexible hours- Overview The Project Manager II provides comprehensive quantitative and qualitative analysis of program and contract data for the Product Manager Biometrics (PM BIO), under the Project Manager Terrestrial Sensors (PM TS), Portfolio Acquisition Executive (PAE), and Layered...Contract work
- Montgomery County Government seeks a Program Specialist II for the Training/Quality Assurance Team within the Division of Fleet Management Services. The role supports training and QA programs across 24/7 operations at multiple locations, coordinating with supervisors,...
- Join the HJF Team! HJF is seeking a Project Manager II who will be responsible for driving successful completion of key deliverables and stated objectives for projects related to Star Behavioral Health Providers (SBHP), a national training and referral initiative that...
- ...company for you! Experience the difference, and let’s talk about your future at Systems Plus today. Position Title Project ManagerLevel II Position Type Full-Time, Remote; occasional on-site requested Position Location Bethesda, Maryland Tracking Code 01203 Daily...Full timeContract workFor contractorsRemote workWorldwide
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