CMC Regulatory Writer for Cell Therapy Submissions (Hybrid)
$33.03 - $41.95 per hourSOKOL GxP Services
SOKOL GxP Services is seeking a Technical Writer and Document Specialist in New Brunswick, NJ, to support CMC documentation for a late-stage clinical cell therapy program. This 12-month hybrid contract requires 50% onsite presence, with responsibilities including authoring CTD Quality sections and managing submission timelines. Candidates should possess a Bachelor’s degree and 2+ years in technical writing for Regulatory CMC documentation. Competitive hourly rate of $33.03 – $41.95 offered, along with health insurance and other benefits. #J-18808-Ljbffr SOKOL GxP Services
$33.03 - $41.95 per hour
...Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will... ...and will support regulatory submission activities, dossier preparation... .... This is a 12-month hybrid contract position based...RegulatoryHourly payContract workWork at officeLocal areaMonday to Friday$38 - $41.8 per hour
...Analyst will sit within the Cell Therapy Development and Operations (... ...responsible for delivering CMC documentation (dossier and supporting... ...documents) to support the regulatory strategy for the Cell... ...to deliver on timelines for submissions. The position interfaces with...RegulatoryHourly payContract workTemporary workWork at officeLocal area- ...Title: Technical writer Location: New... ...Brunswick NJ/ PPK NJ - Hybrid (50% Onsite)... ...will sit within the Cell Therapy Development (CTD)... ...responsible for delivering CMC documentation (... ...) to support the regulatory strategy for a... ...on timelines for submissions. The position...RegulatoryWork at officeLocal areaMonday to Friday
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- Bristol-Myers Squibb is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree...RegulatoryFlexible hours
$115.23k - $139.64k
## Manager, CMC DocumentationNew Brunswick - NJ - USFind out... ...latest breakthroughs in cell therapy, this is work that transforms... ...a technical author of CMC regulatory submissions and specification.The successful... ...may be eligible for a hybrid work model with at least 50...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$115.23k - $139.64k
...the latest breakthroughs in cell therapy, this is work that... ...Manufacturing, and Controls (CMC) Documentation & Specifications... ...a technical author of CMC regulatory submissions and specification. The successful... ...may be eligible for a hybrid work model with at least 50...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeLocal areaRemote workFlexible hoursShift work$278.77k - $337.81k
...Director, E2E Demand & Supply Planning, Cell Therapy Supply ChainNew Brunswick - NJ - USFind... ..., Commercial, Finance, Quality, Regulatory, IT, Procurement) to ensure seamless integration... ...professional development.#LI-Hybrid*If you come across a role that intrigues...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- An established industry player is seeking a Nonclinical Regulatory Document and Scientific Writer to join their dynamic team. This role requires a strong background in DMPK and regulatory drug development, with responsibilities including authoring and reviewing critical...Regulatory
$43 per hour
...Solutions has a client that is immediately hiring for a Regulatory- Technical writer. Position type: Full-time- Contract Duration: 1... ...with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses the health authority questions based on...RegulatoryHourly payFull timeContract workTemporary workWork experience placementWork at officeImmediate startWorldwideFlexible hours- Nonclinical Regulatory Document and Scientific Writer Job #: 2468 Pay Rate: Not Specified Job type: contractor... ...of such documents. Regulatory submissions will span across all therapeutic... ...small molecule, large molecule, and cell therapies. Candidates will support multiple...RegulatoryFor contractorsWork at officeFlexible hours
- ...pivotal role oversees the strategic direction and execution of cell therapy supply chain across global manufacturing sites and partners.... ..., strong leadership skills, and a deep understanding of regulatory standards. Competitive salary and flexible work-life benefits...RegulatoryFlexible hours
- ...oversight during investigations in a GMP environment. The ideal candidate will ensure timely investigations, develop CAPAs, and support regulatory audits. Applicants should have a Bachelor's degree and relevant experience in quality assurance or compliance. This position...Regulatory
- ...clinical scientific leadership for the cell therapy program and have responsibility for our... ...interactions with external collaborators (e.g., regulatory authorities, key opinion leaders,... ...experience with both IND and BLA/NDA submission). Experience in leading study start-...Regulatory
- ...for a contractor to support the Chemistry, Manufacturing, and Controls (CMC) documentation and specifications group. This role includes preparing and managing CMC content for regulatory submissions, collaborating with scientific teams, and ensuring high-quality documentation...RegulatoryHourly payFor contractors
$267.33k - $323.95k
...Director, Internal Site & ExM Supply Chain, Cell Therapy Supply ChainNew Brunswick - NJ - USFind... ...on an exception basis with government regulatory agencies (FDA, Customs) in the event of... ...a cooperative relationship.#LI-Hybrid*If you come across a role that intrigues...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...New Jersey, we are developing advanced cell therapies across a diverse array of technology... ...strategy, ensuring the safety, efficacy, and regulatory compliance of the company's innovative... ...of clinical trials, regulatory submissions, and product commercialization. This...RegulatoryWorldwide
- ...Malaysia is seeking an Executive Director for Regulatory Affairs based in Rahway, NJ. This role involves overseeing the regulatory CMC team and ensuring successful development... ...will be responsible for managing CMC submissions, leading cross-functional teams, and influencing...Regulatory
- ...leading staffing solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the... ...industry. Key responsibilities include coordinating submissions and maintaining regulatory databases. Strong communication and...Regulatory
- The Musculoskeletal Transplant Foundation in Edison, NJ, is seeking a Regulatory Affairs Manager to oversee regulatory submissions, inspections, and audits. This role includes managing the Regulatory Affairs team, budget, and compliance with U.S. and international regulations...Regulatory
- Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals... ...documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards. The ideal...Regulatory
$142.04k - $172.11k
...production line to the latest breakthroughs in cell therapy, this is work that transforms the lives... ...development oversight to assure regulatory compliance across the end-to-end... ...professional meetings and seminars#BMSBL#LI-Hybrid*If you come across a role that intrigues...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Colgate-Palmolive is looking for a Regulatory Affairs Project Manager in Piscataway, NJ, to oversee global regulatory submissions, ensuring compliance with medical device and pharmaceutical standards. The role involves leading cross-functional teams, coordinating quality...Regulatory
- brobstongroup.com - Jobboard is seeking a Specialist, Customs Compliance to manage U.S. import/export and customs regulatory compliance in Piscataway, NJ. This hybrid role requires collaboration with legal and supply chain teams, focusing on compliance for fashion and beauty...Regulatory
- Colgate is seeking a Director, Quality for Skin Health based in Piscataway, New Jersey. This hybrid position requires leading regulatory compliance and quality initiatives across the division while collaborating with various teams to ensure product excellence. The successful...Regulatory
- An established industry player is seeking an IT Quality Compliance Specialist/Analyst to ensure regulatory compliance across the product lifecycle. This hybrid role involves managing the GxP IT Quality Assurance program, reviewing validation deliverables, and supporting...Regulatory
$34.67 per hour
...Job Summary: The RND- Technical Writer is responsible for creating new protocols, revising process validation protocols, manufacturing... ...• Writes and manages department SOP’s, training etc. to ensure regulatory compliance and operations enhancement. Responsible for site...RegulatoryHourly payImmediate startVisa sponsorshipWork visaFlexible hours- ...industry player is seeking a Serialization Data Analyst for a hybrid role that emphasizes data management and standardization within... ...involves leading efforts to ensure data accuracy and compliance with regulatory requirements, while collaborating with various stakeholders to...Regulatory
- ...New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms... ...accordance with internal standards and regulatory expectations. Support process... ...Figures, and Listings (TFLs). #Li-LB1 #Li-Hybrid Please note: These benefits are...RegulatoryPermanent employmentFull timeFor contractorsInterim roleLocal areaWorldwide
- ...biologics development and manufacturing, and cell therapy. GenScript is committed to striving... ...total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as... ...comply with industry best practices and regulatory requirements. Regularly review and...RegulatoryWork experience placement
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