Regulatory Affairs Associate
BioSpace, Inc.
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
$69.8k - $100.05k
...and external vendors. DDD supports efficient preparation of regulatory materials and documentation needed for IND and other regulatory submissions. Key Roles/Responsibilities The Regulatory Affairs Associate will support regulatory strategy and operations to ensure IND...SuggestedFull timeContract workPart timeFor contractorsWork at office$85k - $125k
...leading supplier of high-quality Lentiviral vectors for research and clinical use.We are seeking an exceptional team member to provide regulatory and product development support in a dynamic small company setting.If you are comfortable on the cutting edge and passionate...SuggestedFor subcontractor- Quality Assurance Auditor Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements...SuggestedContract work
$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 people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area- ...Engineering, or related 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...SuggestedFull time
- ...Support data validation activities in our digital tool for oncology regulatory approval information. Help with presentation of regulatory intelligence data analyses using AI tools. Undertake background literature research for regulatory intelligence queries using publicly...Relocation package3 days per week
- Zenith LifeScience is seeking a motivated undergraduate or master's student to support regulatory intelligence activities for oncology regulatory approval information. You will validate data, analyze regulatory guidance, and present findings using AI-assisted tools. The...
$150.1k - $225.15k
...Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to...Temporary workWork at officeFlexible hours3 days per week$208.06k - $262.15k
...standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure... ...with USP.Job SummaryRequisition Number: SENIO003504Job Category: Ext. Affairs, Regulatory, \& CommunicationsSchedule: Full-TimeFull timeWork experience placementWork at officeWorldwide- Benefits Company parties Competitive salary Flexible schedule Opportunity for advancement Training & development This position plays a critical role focusing on the development, training, and successful implementation of our behavioral programs. All behavioral support...Work from homeFlexible hours
- Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support OHRP within the U.S. Department of Health and Human Services. You will review complaints, incident reports, and institutional submissions related to human subjects research, applying the Common Rule...Remote jobPart time
- Position Summary The Early Childhood Specialist I provides grants management support and delivers professional customer service for Head Start, Early Head Start, and Early Head Start-Child Care Partnership grant recipients. The Specialist supports continuous improvement...Contract workWork at officeRemote work
$102k - $118k
Senior Regulatory Analyst (HS/IRB) (Part-Time) Ripple Effect United States Senior Finance Legal 3d ago $102k - $118k About this role... ...clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field. 8...Hourly payFull timePart timeWork at officeLocal areaRemote workFlexible hours- Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions related to human subjects research, assess regulatory significance, and help develop leadership...Remote jobWork at office
- Ripple Effect seeks a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints, incident reports, and IRB submissions, applying knowledge of the Common Rule and research compliance to identify...Work at office
- Global Solutions Network, Inc. (GSN) is seeking a Grants Management Specialist to support the GMP for NIH/NIAID programs. The role involves system updates, workload management, and assisting with grant administration to meet critical business and research milestones. The...Full timeWork at office
- Description** PLEASE NOTE: Salary ranges are geographically based and the posted range reflects the Northen CA region. Lower salary ranges will apply for other labor markets outside of NCALOverview:The Risk Adjustment Operational Analytics leadership is seeking a Data Analyst...Work experience placement
- Roberts Oxygen, a trusted name in industrial, medical, and specialty gases and equipment, is seeking a Fleet Clerk to join our headquarters in Rockville, MD. The Fleet Clerk provides excellent customer service to the Fleet Manager and Operations team, assists with asset...Local area
- Digital Infuzion is seeking professionals for Regulatory Monitoring & DSMB Operations roles in Rockville, Maryland. These positions are crucial for overseeing safety within federally funded clinical research. Responsibilities include supporting DSMB operations, managing...
- ...roles, contribute effectively, and advance the success of the Institute. OSHE furthers this goal by advising the NIST Director and Associate Directors on all matters related to safety, health, and environment (SH&E) to achieve office objectives and advance organizational...Work at office
- ...Institute. OSHE furthers this goal by advising the NIST Director and Associate Directors on all matters related to safety, health, and... ...issues, ensuring the program meets organizational priorities, regulatory obligations, and best practices in laboratory safety and health...Work at officeRemote workWork from homeRelocationFlexible hours
$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust... ..., but are not limited to:Report to Executive Director or Associate Vice President, General MedicineOversee the global...Full timeFor contractorsLocal areaWorldwideFlexible hours$233.7k - $356.3k
...the cross-functional assessments and decisions required to advance product candidates from discovery through clinical development, regulatory approval, and commercialization. The candidate will work closely with leaders across research, clinical, new product planning,...Full timeWork at officeLocal area$92.3k - $166.85k
Leidos has a new and exciting opportunity for a Sr. Compliance Reporting Analyst in our Intel Security Sector's Analysis Solutions Business Area. Our talented team is at the forefront in Security Engineering, Computer Network Operations (CNO), Mission Software, Analytical...Full timeFor contractorsImmediate startFlexible hours- ...procedures when handling telephonic and electronic inquiries from sponsors or applicants, adeptly troubleshooting and resolving issues associated with enrollment and issuance stations. Badging & Credentialing Specialist will promptly report system failures and downtimes to...Full timeFor contractorsWork at officeLocal area
$86.7k - $170.9k
Position Summary Consultant - Regulatory & Compliance - Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team... ...not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At...Local areaVisa sponsorship- Job Description Job Description JUNIOR GRC ANALYST ROCKVILLE, MD - HYBRID LONG TERM CONTRACT SEEKING SOMEONE WHO HAS WORKED WITH THE SERVICENOW GRC APPLICATION Overview: ~ The GRC Analyst supports the administration of Information Security Governance, Risk, ...Long term contractInternship
- Hassle Free Home Services, Inc. is seeking a detail-oriented Bookkeeper to oversee the full transaction cycle, including payables, receivables, reconciliations, payroll, and compliance tasks across markets. You will work closely with our accountant and CFO to ensure timely...
$140k - $195k
...Security management in creating and implementing security plans for the construction phase of the Xe-100 plant, ensuring alignment with regulatory requirements and industry best practices.Support the development and implementation of Access Authorization and Fitness for Duty...For contractorsWork at officeLocal area$71k - $90k
...record documentation. Maintains GMP documentation supporting the company's facility. This activity is essential for maintaining regulatory compliance and preparing for pre-approval and general inspections by various regulatory agencies. Maintains the QA compliance systems...Work at officeVisa sponsorshipFlexible hours
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