Senior Regulatory Affairs Scientist — FDA Strategy & Compliance
CICONIX, LLC
CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure compliance with FDA regulations. The ideal candidate will possess a RAC certification and have experience with regulatory strategy for medical products. This full-time position requires a thorough understanding of regulatory matters related to submissions and communication with the FDA. A comprehensive benefits package is included. #J-18808-Ljbffr CICONIX, LLC
- CICONIX LLC in Fort Detrick, MD is seeking a Senior Regulatory Affairs Scientist to support the ORA for DHA R&D MRDC. The role focuses on FDA regulatory strategy, risk assessment, and regulatory submissions to CDER, CBER, and CDRH. You will serve as SME, coordinate document...Senior
- ...Description Job Description Description: Senior Regulatory Affairs Scientist Venesco LLC is seeking a Senior... ...for developing regulatory strategies, leading FDA interactions, managing submissions, and ensuring compliance throughout the medical product lifecycle...Senior
- Senior Regulatory Affairs Scientist Full-time position Regular weekly hours (0900-1600) Full benefit... ...Detrick, MD. About The Role Ensure compliance with FDA Sponsor responsibilities, serve as... ...matter expert for regulatory strategy including identifying and mitigating...SeniorFull timeContract workWork at officeNight shiftWeekend work
- ...opportunity to make a personal impact as a Senior Human Su bjects Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Office of Human Research... ...Federal, DoD, Food and Drug Administration (FDA), state, host nation, and DHA R&D human...SeniorContract workWork at officeLocal areaRemote work
- Precision for Medicine seeks a Director-level CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA, EU IVDR, and other requirements into practical plans, working with pharmaceutical and...Senior
- Sr Principal Scientist - Standardized Organoid Modeling CenterJob ID: req4604Employee Type... ...services. KEY ROLES/RESPONSIBILITIESThe Senior Principal Scientist - Hepatic Organoid position... ...scientific research and/or development strategies in research and/or development.Exercises...SeniorFull timePart timeWork at office
$130k - $200k
...disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl... ...motivated and innovative Principal Scientist with a background in immunology, autoimmunity... ...innovative discoveries and optimization strategies that align with industry’s best...Temporary workWork experience placementLocal areaFlexible hours- ...CICONIX, LLC is seeking a Senior Technical Product Manager based in Fort Detrick,... ...product technical operations, managing regulatory compliance, and providing support for investigational... ...include overseeing product strategies and collaboration with cross-functional...SeniorFull time
- ...Frederick, Maryland is looking for a Quality Control Scientist II to develop analytical methods and oversee sample testing. The role involves ensuring compliance with cGMP standards and preparing documentation for regulatory agencies. The ideal candidate possesses a PhD and...Senior
- A leading scientific services provider is seeking a Senior Scientist - Histology Technician to support the National Institute of Allergy and Infectious Diseases. This role involves providing histology services, conducting molecular pathology experiments, and operating...SeniorWeekend work
$84k - $97k
A leading jewelry company is looking for a Workforce Management Manager in Frederick, MD. The role involves creating schedules, ensuring optimal staffing levels, and reporting on workforce metrics. Candidates should have a Bachelor's degree and 5+ years of relevant experience...Senior$85k - $92k
Senior Human Subjects Protection Scientist CICONIX is seeking a Senior Human Subjects Protection Scientist with... ...for site visits (monitoring, non‑compliance) to include preparation and planning... ...either an IRB office or regulatory office. Current training in humans...SeniorContract workWork at office- DSV is seeking an on-site Senior P&O Business Partner in Frederick, MD to support HR functions across recruitment, employee... ...with clients to align HR solutions with business strategies and ensures compliance and effective HR processes. The position requires a Bachelor...Senior
- NBACC at Fort Detrick conducts advanced mass spectrometry to identify toxins in forensic samples, supporting national biodefense. The role develops and validates MS methods, operates MALDI TOF and Orbitrap systems, and ensures accurate LIMS documentation. You’ll mentor ...Senior
- Frederick National Laboratory for Cancer Research seeks highly qualified researchers in the Laboratory Animal Science Program (LASP) at Ft Detrick. The role emphasizes tissue engineering and biomedical engineering to support organoid modeling and preclinical research. Applicants...Senior
- Australia-Employment is seeking a dynamic Tax Principal to manage tax planning and compliance in a hybrid working environment. Located in Frederick, MD, this role requires strong leadership and expertise in tax law. Join our professional services firm that values individuality...
- Scientist II, Standardized Organoid Modeling CenterJob ID: req4623Employee Type: exempt full-timeDivision: Laboratory Animal Science ProgramFacility... ...all pre-clinical scientific research and/or development strategies.Exercising independent judgment in developing methods,...Full timePart timeWork at office
- Scientist II, Stem Cell Lab (IPSC)Job ID: req4635Employee Type: exempt full-timeDivision... ..., cellular assays, and quality control strategies to generate reproducible, scalable, and... ...of laboratory resources, and ensuring compliance with biosafety and quality standards.Remaining...Full timePart timeTraineeshipWork at office
- ...Product Technical Operations Scientist Venesco LLC is seeking... ...successful product development and regulatory approvals. Requirements:... ...Support manufacturing strategy development. Review product... ...experience. Knowledge of FDA regulatory requirements, GMP,...
$70.82 per hour
Sr. Scientist - Histology Lab Manager - (8333) Cape Fox Facilities Services (CFFS) is seeking an experienced Histology Lab Manager to support... ...methodology and instrumentation under the direction of the Senior Veterinary Pathologist and oversees organization and management...SeniorHourly payFor contractorsRemote workMonday to Friday- ...resource management firm expert in meeting local, state, and federal regulatory requirements. Our nationwide practice is supported by full-... ...identification, to the development and execution of treatment strategies for heritage resources. Our team of experts is distinguished...Contract workWork at officeLocal area
$60k - $90k
...disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl... ...is seeking a highly motivated Associate Scientist to join our multidisciplinary R&D team... ...Document and communicate results in reports, regulatory filings, and presentations to internal...Temporary workLocal areaFlexible hours$133.2k - $172.37k
...MSAT, commercial QC, and/or CMC analytical control strategy to join us as Sr QC specialist/ Scientist at our Fredericks, MD location. The individual will... ...groups with MSAT, process development, quality, and regulatory to provide analytical support to commercial assets....Temporary workLocal area$26 per hour
...GMP systems currently in place to ensure compliance with documented policies. Review... ...procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric... ...with all applicable state and local laws. Seniority level Associate Employment type Contract...Contract workFor contractorsLocal areaShift work$70.82 per hour
Sr. Scientist - Histology Technician - (8334) The total hourly pay for this exempt position is $70.82 for up to 40 hours per week. This... ...withdrawn. Cape Fox Facilities Services is seeking an experienced Senior Scientist - Histology Technician to provide services in support...SeniorHourly payFor contractorsWork at officeRemote workMonday to Friday- The Planet Group is seeking a Quality Control Chemist in Frederick, MD for onsite role. The candidate will perform testing on raw materials to final products using bioassays, flow cytometry, ELISA and qPCR, and will maintain lab readiness and data integrity in a regulated...
$75k - $85k
...central element of our overall business strategy. Visitdsv.com and follow us onLinkedInandFacebook... ...Division:Solutions Job Posting Title: Senior P&O Business Partner Time Type: Full... ..., job descriptions, local and country compliance, management and employee training,...SeniorFull timeWork experience placementLocal area$122.6k
...make a difference and change the world. Job Description The Senior Manager, Office Space Planning & Construction leads the... ...office environment. This role is accountable for aligning workplace strategy with business growth, hybrid work models, cost efficiency, and...SeniorContract workFor contractorsWork experience placementH1bWork at office- Scientist I, Standardized Organoid Modeling LabJob ID: req4574Employee Type: exempt full-timeDivision: Laboratory Animal Science ProgramFacility: Frederick: Ft DetrickLocation: PO Box B, Frederick, MD 21702 USAThe Frederick National Laboratory is operated by Leidos Biomedical...Full timePart timeWork experience placement
$110k - $135k
A defense technology firm located in Maryland is seeking a Senior Blast Analyst to provide expert analysis on blast effects and support injury prevention strategies for the Department of Defense. Candidates should have advanced experience in blast mechanics and injury biomechanics...Senior
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