Regulatory Specialist
Zenith LifeScience LLC
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 available and commercial tools. Research and analyze regulatory guidance, precedence to support our products and development pipeline 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 available and commercial tools. Research and analyze regulatory guidance, precedence to support our products and development pipeline Experience with data analysis, presentation skills, and ability to search in external sources required. Experience or interest in digital/AI/automation and the regulatory field an added plus. Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design. Position Requirements Junior and senior undergraduate or Masters student majored in a Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or a related field. US Work Authorization is required at time of application. Ability to report onsite to Gaithersburg, (Rio location) MD 3-5 days a week. This role will not provide relocation assistance. #J-18808-Ljbffr
$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- Vector BioMed, Inc. in Gaithersburg, MD, seeks a regulatory and product development professional to support Master File submissions and regulatory communications for ATMPs and CGT products. The role requires a BS in a scientific field and at least 5 years in regulatory...Suggested
- 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...Suggested
$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...SuggestedFull timeLocal area- Job Description Job Description Job Type: Full Time Location: Columbia, Md. Clearance: TS/SCI w/Polygraph VMR Strategic Solutions is seeking a Privacy and Compliance Officer. Are you interested in joining a dynamic team that provides crucial support to USCYBERCOM...SuggestedFull time
- ...Job Title Regulatory Specialist Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Salary Range 70,000.00-85,000.00/YEAR Education Bachelor's Degree Travel None Job Description Prepare,...Full timeWork at officeLocal areaRemote work
- ...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
$24 - $27.5 per hour
Job ID: 290930 Store Name/Number: MD-Pike & Rose (1120) Address: 11878 Grand Park Ave, North Bethesda, MD 20852, United States (US) Hourly/Salaried: Hourly (Non-Exempt) Full Time/Part Time: Part Time Position Type: Regular Your Role at Sephora: As a...Hourly payFull timePart timeFlexible hoursShift workNight shiftWeekend work- 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...Contract work
- 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...
$208.06k - $262.15k
...increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally...Full timeWork experience placementWork at officeWorldwide- Job Description Job Description 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...Work from homeFlexible hours
$25.35 - $39.32 per hour
...Employment Type: Full time Shift: Description: Job Title: Credentialing Specialist Employment Type: Full-Time Shift: Monday-Friday, day shift Location: Germantown Hospital Position Purpose Coordinates and supports the Medical Staff's credentialing process, including supporting...Hourly payFull timeLocal areaMonday to FridayFlexible hoursShift workDay shift- ...more at the OpportunityThe Fire Alarm Monitoring Compliance Specialist will be responsible for overseeing the monitoring services for... ...systems across all our company locations, ensuring compliance with regulatory standards and company policies. The ideal candidate will have...Temporary workLocal area
$150.1k - $225.15k
...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 help business...Temporary workWork at officeFlexible hours3 days per week$102.41k - $117.77k
...human subjects research is conducted ethically and in compliance with federal regulations? Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB)to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human...Full timeWork at officeRemote workFlexible 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
- Summary: VIAVI (NASDAQ: VIAV) VIAVI is a global provider of network test, monitoring and assurance solutions for telecommunications, cloud, enterprises, data centers, first responders, military, aerospace, railway and instrumentation markets. Also, Viavi is a global leader...Full timeWork at officeWork from homeWorldwideHome office
- ...Foundation for the Advancement of Military Medicine, based in Bethesda, MD, seeks a Research Coordinator II to write, edit, and package regulatory documents for assigned centers, ensuring all sponsors' protocols progress to IRB approval. You will support the Research...Work at office
- Eagle Creek Renewable Energy, LLC seeks a Compliance Analyst to join our Regulatory Affairs Team in Maryland. This role supports licensing and regulatory compliance across hydroelectric projects, tracking obligations and coordinating permit activities with internal teams...
- Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP's compliance oversight mission by reviewing complaints...Remote jobWork at office
- Eagle Creek Renewable Energy seeks a Compliance Analyst to join its Regulatory Affairs Team. The role will support licensing and regulatory requirements, track compliance obligations, oversee permitting, and collaborate with internal and external stakeholders. Ideal candidates...
- 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
- Ripple Effect seeks a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions, evaluate compliance, and support case management with IRBs and institutions. Strong attention to...Remote jobWork at office
- Chief Safety Officer The Chief Safety Officer of the Office of Safety, Health, and Environment (OSHE) at NIST promotes and sustains a strong, integrated safety culture that enables staff at all levels to understand their roles, contribute effectively, and advance the...Work at office
- ...engagement with stakeholders. Provide authoritative guidance on SH&E issues, ensuring the program meets organizational priorities, regulatory obligations, and best practices in laboratory safety and health. Requirements Conditions of Employment Qualifications Candidates...Work at officeRemote workWork from homeRelocationFlexible hours
$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...Full timeFor contractorsWork at officeLocal area- ...NIST through leadership, communication, and continuous engagement with stakeholders. # Provide authoritative guidance on SH&E issues, ensuring the program meets organizational priorities, regulatory obligations, and best practices in laboratory safety and health....Remote work
- 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
$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
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