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.
$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- Technical Resources International, Inc. is seeking a Regulatory Administrative Support professional to assist with documentation and filing in support of regulatory submissions. The role emphasizes accuracy, timely delivery, and high-quality communication with colleagues...Suggested
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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- ...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...SuggestedWork at office
$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$102.41k - $117.77k
...Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB)to support the Office... ...complaints, incident reports, and institutional submissions related to human subjects research. You... ..., biomedical sciences, regulatory affairs, law, public administration, or a related...Full timeWork at officeRemote workFlexible hours$186.23k - $279.35k
...breakthrough programs, where your regulatory leadership translates... ...pioneering science into high-quality submissions and decisive health authority... ...; represent CMC regulatory affairs on product teams and in... ...multiple regions. Expertise in CGT-specific comparability...Hourly payTemporary work3 days per week- Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support OHRP within the U.S. Department of Health and Human Services... ...will review complaints, incident reports, and institutional submissions related to human subjects research, applying the Common Rule...Remote jobPart time
- Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the... ...by reviewing complaints, incident reports, and institutional submissions related to human subjects research. You will assist with the...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 and submissions, evaluate compliance, and support case management with IRBs and institutions. Strong attention to...Remote jobWork at office
$233.7k - $356.3k
...product candidates from discovery through clinical development, regulatory approval, and commercialization. The candidate will work... ...discovery, IND-enabling activities, clinical development, regulatory submission, approval, and commercialization. Drive the creation,...Full timeWork at officeLocal area$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and... ..., China, and JapanPrior GRL oversight of global regulatory submissions and approvals, including IND/CTAs and NDA/BLAsKnowledge and...Full timeFor contractorsLocal areaWorldwideFlexible hours$225k - $300k
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Regulatory Affairs Director - OncologyLocation: USA - Gaithersburg MD, Canada- MissisaguaWould you like to apply your Regulatory Affairs... ...you'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$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San... ...authorities, define target product labeling, and accelerate submissions across multiple indications and modalities. As a senior...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$55k - $81k
...About the Position The Regulatory Compliance Coordinator prepares, submits and maintains... ...or healthcare experience desired ~ IRB submission and/or compliance monitoring experience... ...study information is approved by the Public Affairs Office Stay up-to-date in all...Work experience placementInterim roleWork at officeLocal areaSleeping nightsFlexible hours- ...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...
- 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
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...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- ...have 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...Remote 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...Work at office
- 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...
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...longer-term plans to address emerging regulatory changes. This individual will take a strategic... ...-paced environment with time-sensitive submissions and strict reporting deadlines.Strong... ..., two (2) Trade Compliance Specialists.BenefitsUSP provides the benefits to protect...Full timeWork at officeImmediate startWorldwide- ...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
$109.25k - $163.87k
...with those of people from all over the globe. As a Nonclinical Submission/ Established Brand Manager within the Nonclinical Submission... ...preparation and finalisation of all nonclinical contributions to regulatory submissions. You will also play a key role in the maintenance...Hourly payTemporary workWork at officeFlexible hours3 days per week$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- 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
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- ...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
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