Regulatory Affairs Specialist II - IND & Submissions
Frederick National Laboratory for Cancer Research
Frederick National Laboratory for Cancer Research seeks a Regulatory Affairs Associate to support IND readiness and regulatory submissions. You will coordinate documentation, liaise with NIH teams, CROs, and vendors, and ensure compliant, submission-ready files. The role requires strong regulatory writing skills, experience with IND-enabling studies, and knowledge of 21 CFR Part 312. A proactive, detail-oriented team player will thrive here. #J-18808-Ljbffr Frederick National Laboratory for Cancer Research
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist II - IND & Submissions in Rockville, MD vacancy
$69.8k - $100.05k
...efforts include preclinical and IND-enabling development programs... ...supports efficient preparation of regulatory materials and documentation... ...needed for IND and other regulatory submissions. Key Roles/Responsibilities The Regulatory Affairs Associate will support...SuggestedFull timeContract workPart timeFor contractorsWork at office- AstraZeneca is seeking a Regulatory Affairs Associate to support regulatory management and license applications in line with AZ standards. You will manage regulatory files, assist with submissions, and serve as an interface with Health Authorities for task execution. The...Suggested
- AstraZeneca in Gaithersburg, MD is seeking an energetic Regulatory Affairs Associate to support licenses and applications aligned with regulatory... .... You will manage document control, assist with simple submissions, and act as an interface with Health Authorities while...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
Kaiser Permanente
Rockville, MD21 hours ago - ...consistently striving for the highest standard of technical knowledge, creativity and execution.Job DescriptionThe Project Coordinator II assists the Project Manager in delivery of small- to large-scale capital design and construction projects in biopharmaceutical,...SuggestedFor subcontractor
$75k - $85k
A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree and strong communication skills. Candidates should have knowledge of Microsoft Office...Work at officeRemote work$140k - $160k
...Program Manager II Department ATCC Federal Solutions Role Type onsite Category ATCC Federal... ...Biologics, Biorepository, Biotechnology, Cell Biology, Cryobiology, Regulatory Science Overview Ready to shape the future of science and...Contract workTemporary workATCC
Gaithersburg, MD21 hours ago$178.53k - $267.8k
Regulatory Affairs Director - OncologyLocation: USA - Gaithersburg MDWould you like to apply your Regulatory Affairs strategy expertise... ...'ll do:Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions,...Hourly payFull timeTemporary work3 days per week$67.5k - $97.4k
Overview HJF is seeking a Project Manager II to assist in the successful completion of key deliverables and objectives for the Military... ...solicitation, documentation preparation, and supply request submissions in Oracle. Manage and audit the Ecosystem partner distribution...Work at office$85.94k - $137.38k
...dynamic and highly skilled Program Manager II with professional experience in the... ...program, and adapt to evolving community and regulatory needs. We welcome applicants who are... ...will lead a team of planning and program specialists and oversee all aspects of the program—from...Contract workFor contractorsCasual workWork at officeLocal areaAfternoon shift- ...unwavering subscription to three fundamental tenets: Partnership, Integrity, and Innovation. POSITION SUMMARY: The Operations Specialist II, also referred to as the Virginia Newspaper Liaison, is a hybrid position in the VA Foreclosure Department and is responsible...Full timeWork at officeLocal areaRemote workFlexible hours
Aldridge Pite LLP
Rockville, MDmore than 2 months ago - ...oncology medicines and influence regulatory decisions that impact... ...changing medicines. As a Regulatory Affairs Director, you will play a... ...initiatives across development, submission, approval and lifecycle... ...regulatory submissions, including INDs, NDAs and BLAs.Driving...Hourly payFull timeTemporary workWorldwide
- The Clinical Regulatory Writing team provides expert communications leadership to drug projects... ...excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing... ...clinical submissions, such as MAA, IND, and NDA.) #J-18808-Ljbffr Zenith LifeScience
- CRB in Rockville, Maryland, is seeking a Project Coordinator II to assist the Project Manager in managing capital design and construction projects within the biopharmaceutical and advanced technology sectors. The role involves directing and coordinating with various stakeholders...
- ...experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience).... ...and/or review of technical areas for IND/BLA preparation, labeling, operations,... ...of the planning, preparation and submission process for IND and licensing applications...Work at office
$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion... ...affairs preferred.Experience leading regional development, submission and approval activities in local region(s).Experience with...Full timeLocal area- The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licenses... ...regulatory requirements. Planning, preparing and executing simple submissions, and assisting with the preparation and planning of...Hourly payTemporary work
- ...Location: Bethesda, Maryland City/Cities Location Details: Bethesda, Maryland Job Code: 6379Job Title/Grade: Project Manager I/II, Senior Project Manager I (8-10)Department: Delivery, AfricaReports to: Director, PDTOrganization and ValuesDAI is a global development...Contract workTemporary workFor subcontractorWorldwideHome office
- ...Job Title Regulatory Specialist Location Bethesda, MD 20817 US (Primary... ...Category Regulatory Affairs Job Type Full-Time... ...distribute, and track regulatory submissions including, drug and... ...Investigational New Drug Applications (INDs), Biologics License...Full timeWork at officeLocal areaRemote work
TRI
Bethesda, MD1 day ago - HMSHost Corporation seeks an HRIS Analyst II to maintain HRIS and payroll integrations at the North America Support Center in Bethesda, MD. You will ensure data integrity and optimize cross‑platform data flows for HR and Payroll teams. The role requires 5+ years in HRIS...
$72.57k - $107.15k
...children with IDD, the transitioning youth process, experience conducting outreach, and have strong communication skills. The Program Specialist II will serve as a Community/Transitioning Youth Navigator in the My Turn Program. This position will provide navigation/case...Local areaRemote workWeekend workAfternoon shift- ...are seeking a global Executive Director, Regulatory Affairs (level determined by candidate... ...Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the... ...of US and eventually global regulatory submissions to achieve timely approvals of biologic...
- Montgomery College is seeking an Employee and Labor Relations Specialist II to provide collegewide HR subject matter expertise in labor relations. The role emphasizes open communication, positive relationships with management and unions, and partnership with other HR units...Remote workMonday to Friday
- ...Job Description Job Description SUMMARY The Financial Advisor II is primarily responsible for supporting the senior financial advisor(s) and principals of the firm in all aspects of giving advice and conducting client meetings. He/she also works in collaboration...
FSA Wealth Partners, Inc.
Rockville, MD5 days ago $80k - $100k
...services to ensure compliance with statutory, regulatory, and HHS policy requirements. Support... ...evidence. Develop reports and submissions required by HHS, OMB, ASFR, PSC, and other... ...Financial Management Analyst I & II Minimum of ten (10) years of experience...Full timeContract workFor contractorsWork at officeH R Computer Consulting Services
Rockville, MD1 day ago- ...Project Manager II 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 (...Contract workTemporary workImmediate startFlexible hours
Integral Federal
McLean, VA3 days ago - ...required; US Citizenship preferred*Remote Position TBD*Applicants residing in the DMV area preferred as the client is located in Silver Spring, MD*Three references requiredPOSITION DESCRITPION:The Project Manager II will provide senior executive leadership, strateg......Remote work
Think Tank Inc
Silver Spring, MD21 hours ago - 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...
- ...with the SEC. Under team supervision, you will process and review requests, gather data, and ensure documents are ready for EDGAR submission. The role requires 1-2 years of experience with EDGAR documents, strong SEC form knowledge, and proficiency in MS Office and PDF...Remote job
- Montgomery County DEP in Rockville, MD, seeks a Program Manager II to lead the RainScapes program, guiding strategy, outreach, and contractor training. You will manage budgets, contracts, and reporting while mentoring a multidisciplinary team. The role requires five years...For contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist II - IND & Submissions. Be the first to apply!
Related searches
- compliance coordinator Rockville, MD
- regulatory specialist Rockville, MD
- compliance associate Rockville, MD
- risk and compliance analyst Rockville, MD
- regulatory officer Rockville, MD
- compliance specialist Rockville, MD
- compliance officer Rockville, MD
- regulatory affairs specialist Rockville, MD
- coding compliance specialist Rockville, MD
- healthcare compliance officer Rockville, MD