Regulatory Affairs Specialist for CGT & ATMP Submissions
Vector BioMed, Inc.
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 support, with strong technical writing and cross-functional collaboration skills. Industry experience with FDA-regulated products is preferred. #J-18808-Ljbffr Vector BioMed, Inc.
- 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...Suggested
$85k - $125k
...exceptional team member to provide regulatory and product development support... ...Prepare new Product Master File submissions and maintain existing product Master... ...therapy medicinal products (ATMPs), including cell and gene therapy (CGT) products Key skills and experience...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...SuggestedWork at officeRemote work- ...motivated and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience). This role is... ...responsibility.Management of the planning, preparation and submission process for IND and licensing applications. Specifically assisting...SuggestedWork 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...SuggestedFull timeLocal area$69.8k - $100.05k
...CROs), 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...Full timeContract workPart timeFor contractorsWork at office$109.24k - $163.87k
The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading... ...The RAM contributes to regulatory submission strategy, identifying submission... ...RPM Regulatory skill group in CGT Marketing Companies Health Authorities...Hourly payTemporary work- ...gene therapies.We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience)reporting into the... ...and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and...
$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...Health Authority interactions through major submissions and post-approval maintenance—helping... ...regulatory strategy for a complex CGT product or indication from current stage...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...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
$225k - $300k
...conducting their own business development activities from deal identification, qualification, and capture to proposal development and submission. Duties include: Developing and implementing a comprehensive business development plan. Identifying and pursuing new...Contract work$178.53k - $267.8k
Regulatory Affairs Director - OncologyLocation: USA - Gaithersburg MDWould you like to apply your Regulatory Affairs strategy expertise and... ...you'll do:Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label...Hourly payFull timeTemporary work3 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco... ..., define target product labeling, and accelerate submissions across multiple indications and modalities. As a senior leader...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$266.6k - $399.9k
...respiratory and immunology modalities for patients. As part of our Regulatory Affairs team, you will play a crucial role in bringing these... ...to have. Experience in global regulatory strategy and submissions that have progressed through to registration Must have significant...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...future of oncology medicines and influence regulatory decisions that impact patients globally?... ...-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in... ...initiatives across development, submission, approval and lifecycle management activities...Hourly payFull timeTemporary workWorldwide
- The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical... ...strategic communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Associate...
- AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States... ...shaping global regulatory strategy for CGT programs spanning oncology and immune-... ...from expedited designations to major submissions, ensuring patient value and global #J-...
- ASSYST is seeking an Information Security Governance, Risk & Compliance (GRC) Analyst to support our client in administering and maintaining an established enterprise Information Security Governance, Risk, and Compliance (GRC) program. This role will focus on managing Information...Work at officeLocal 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...Full time
- ...with whom a signed agreement and a duly authorized work order (for a specific role)has been duly executed. Any unsolicited candidate submissions or candidate submissions from Agencies that do not meet these criteria, will be deemed invalid and ineligible for any fees....Hourly payTemporary workFor contractorsLocal areaMonday to FridayShift workWeekend workAfternoon shift
$269k - $328.9k
...including R&D, Quality, Manufacturing, and Regulatory Affairs, to the successful development of... ...technology strategies, adhering to CTO CGT governance processes.Drive innovation by... ...ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents...Full timeWork at office3 days per week- ...just the opportunity for you. Position Summary The Data Quality Analyst will play a key role in evaluating scientific data submissions across the translational research continuum, ensuring accuracy, completeness, and adherence to established standards. This role requires...Full timeRemote work
- ...from Germany to the United States. Drive Regulatory/ Operational Oversight: Oversee import/... ...action with customs administrative entry submission as appropriate with support of 3PL,... ...supply chain, quality, legal and Regulatory Affairs to ensure timely and compliant product movement...Full timeLocal area
- Mid-Atlantic FCU in Germantown, MD seeks a Certified ACH Specialist to manage ACH transactions, reconciliations, and compliance with NACHA... ...general ledger accounts, and helps with internal audits and regulatory examinations as needed. Strong ACH software knowledge is...Full time
- Financial Industry Regulatory Authority, Inc. in Rockville, MD seeks an Operations Analyst to support management of criminal justice information (CJI) under FBI CJIS. You will monitor training, ensure CHRI compliance, and operationalize FBI policy into auditable activities...
$100.04k - $142.56k
...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 at officeRemote workWorldwide$133.04k - $199.56k
Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to... ...for excellence in communication to achieve successful submissions and approvals. Accountabilities Independently manage clinical...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...focused on oncology and hematology is seeking a Director of Regulatory Affairs to support an expanding portfolio of programs spanning development... ...strategy and execution, with a primary focus on leading NDA submission activities and supporting programs through approval and post...
- 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
...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
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