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
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Writer for Cell Therapy Submissions (Hybrid) in New Brunswick, NJ vacancy
- Spectraforce Technologies is seeking a Technical Writer and Document Specialist in New Brunswick, NJ. The role involves creating and managing CMC documentation for regulatory submissions in the cell therapy field. Responsibilities include collaboration with technical teams...RegulatoryWork at office
- ...JOB TITLE: Technical writer Location: New Brunswick... ...) will sit within the Cell Therapy Development (CTD)... ...responsible for delivering CMC documentation (dossier... ...) to support the regulatory strategy for a late-stage... ...deliver on timelines for submissions. The position...RegulatoryWork at officeLocal area
ECLARO
New Brunswick, NJ20 hours ago $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... ...This is a 12-month hybrid contract position based...RegulatoryHourly payContract workWork at officeLocal areaMonday to Friday$38 - $41.8 per hour
Bristol Myers Squibb is seeking a contractor for the CMC Documentation and Specifications group. This role involves supporting... ...of Chemistry, Manufacturing, and Controls (CMC) content for regulatory submissions. The contractor will ensure high-quality documentation and...RegulatoryHourly payFor contractors- ...we are developing advanced cell therapies across a diverse array of technology... ...the safety, efficacy, and regulatory compliance of the company's... ...clinical trials, regulatory submissions, and product... ...plus. #LI-AS1 #Li-Hybrid The base pay range below...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours
Legend Biotech US
Somerset, NJ1 day ago $80.6k - $145k
Project Manager I – Cell & Gene Therapy (Sponsor-Dedicated/ Hybrid) Syneos Health® is a leading fully-integrated life sciences services organization built... ...enrollment , working closely with site monitors, regulatory teams, and contracts personnel. Serve as a key point...RegulatoryFull timeContract workWork experience placementWork at officeRemote workFlexible hours- ...CMC Dossier Sciences Team Member The CMC Dossier Sciences department within client... ...the preparation of CMC dossiers for regulatory submissions to enable advancement of company's product... ...of CMC development for Biologics: Cell line development, Formulation, DS/DP aseptic...Regulatory
Aequor Inc
Piscataway, NJ3 days ago $360k - $400k
...company advancing gene therapies with curative... ...where a senior level regulatory affairs leader will be... ...clinical, non-clinical and CMC approval pathways across... ...regulations for a variety of submission documents, including... ...vaccines as well as cell and gene therapy...RegulatoryTemporary workLocal areaShift workRocket Pharmaceuticals
Cranbury, NJ4 days ago$150k - $200k
...commitment to bringing cost-effective therapies to market with speed, quality... ...a high-caliber, strategic Regulatory Affairs Director to lead our... ...for 505(b)(2) products. Submission Oversight: Provide executive... ...(clinical, analytical, and CMC) to ensure they exceed the...RegulatoryFull timePrinston Pharmaceutical Inc.
Somerset, NJ2 days ago- Legend Biotech is seeking a Program Lead for Cell and Gene Therapy in Raritan, NJ. This role involves developing the commercial manufacturing... ...in biopharmaceutical manufacturing and a strong grasp of regulatory standards. The position includes a competitive salary and comprehensive...Regulatory
$68.05k - $109.87k
...provide quality oversight during the investigation of events in the production of cell therapy products. Responsibilities include ensuring timely and accurate investigations, supporting regulatory inspections, and maintaining compliance with standards. Candidates should...Regulatory$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$200k - $245k
Initial Therapeutics, Inc. is searching for a Regulatory Affairs Director in South Brunswick, NJ.... ...a hands-on professional to manage NDA submissions and cross-functional execution for a... ...NDA submissions. The position offers a hybrid work environment and a competitive salary...Regulatory- ...Sr. Regulatory Affairs Specialist A Few Words About Us Integrated Resources, Inc is a... ...IT), Clinical Research, Rehabilitation Therapy and Nursing. This is a Direct Hire role... ...will be responsible for regulatory submissions for new ANDAs and any changes being made...Regulatory
Careers Integrated Resources Inc
Edison, NJ4 days ago - ...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
$140k - $200k
...Environmental Attorney – Princeton, New Jersey – Hybrid Remote Founded over 100 years ago, we are a full-service law firm that clients... ...and private sector clients on a broad range of environmental regulatory, permitting, compliance, transactional, and litigation matters....RegulatoryLocal areaRemote workPinnacleConnect LLC
Edison, NJ1 day ago$90k - $210k
...be identifying and assessing regulatory and quality risks during... ...transfer of late stage/commercial cell therapy products and equipment... ...implementation plans Contribute to CMC sections of regulatory... ...experience in preparing regulatory submissions and response to health...RegulatoryFull timeFlexible hours$85k - $105k
...biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards its vision of... ...documentation. Conduct compliance audits to ensure full regulatory compliant with accurate filings and duties, and lead corrective...RegulatoryGenScript Biotech
Piscataway, NJ3 days ago- ...Regulatory Affairs Specialist (Hybrid) Hybrid - Warren NJ About Spectrum Vascular Spectrum Vascular is an innovative medical device company... ...Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device...RegulatoryInternshipWork at officeWorldwide
Spectrum Vascular
Bridgewater, NJ3 days ago $25 - $28.17 per hour
...Type: Contract Compensation: $25-$28.17/hr Work Model: Hybrid - onsite and remote Responsibilities Lead the end-to-end... ...Diagnostics (IVD) technical writing of IFUs ~ Familiarity with regulatory requirements (IVDR, FDA) ~ Experienced in collaborating with cross...RegulatoryFull timeContract workLocal areaRemote workSystem One
Somerville, NJ20 hours ago$256.07k - $336.1k
...New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms... ...industry trends (CAR-T evolution, regulatory updates, partnership models) and... ...globally collaborative. #Li-JK1 #Li-Hybrid The base pay range below is what...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift workLegend Biotech US
Bridgewater, NJ1 day ago- ...pharmaceutical industry, is seeking a Medical Writer II to join their team. As a Medical... ...Response Documents (VDRs) and other submission-related materials Create landscape decks... ...strategic initiatives Support development of regulatory content aligned with internal standards...RegulatoryWeekly payTemporary workRemote workFlexible hours
$68.05k - $109.87k
...ensuring compliance with manufacturing standards. Responsibilities include managing investigations, developing CAPAs, and supporting regulatory audits. Benefits include comprehensive health insurance, parental leave, and a performance-based bonus. Salary range is $68,045—$...Regulatory$232k - $277k
...company advancing gene therapies with curative... ...with company objectives, regulatory expectations, and product... ...available to support CMC and all Regulatory filings... ...in Molecular Biology, Cell Biology, Immunology,... ...sections of regulatory submissions. Strong abilities in...RegulatoryContract workTemporary workLocal areaShift work- Katalyst CRO in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree in Pharmacy or Life Sciences, with 5-10 years of experience in eCTD/NeeS publishing. Responsibilities...Regulatory
- ...policies, facilitating stakeholder communication, and ensuring regulatory compliance. The ideal candidate must possess strong analytical... ...relevant certifications such as LOMA or CBAP. This position offers a hybrid work arrangement based in Piscataway, NJ. #J-18808-Ljbffr...Regulatory
$62 - $76 per hour
...pharmacy focused on hormone replacement therapy is seeking a qualified pharmacist to serve... ..., leading the licensure process from submission through board inspection and approval... ...Maintain audit readiness and serve as primary regulatory contact Hire, train, and manage...RegulatoryContract workSoliant Health
Edison, NJ4 days ago- ...quality oversight for Third-Party Vendors, ensuring compliance with regulatory requirements while maintaining the Quality Agreement Master... ...skills, and proficiency in Microsoft 365. This role offers a hybrid work arrangement and a comprehensive benefits package. #J-1880...Regulatory
$80k - $90k
...biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards its vision of... ...all operations comply with industry best practices and regulatory requirements. Regularly review and update SOPs to adapt to...RegulatoryWork experience placementGenScript Biotech
Piscataway, NJ1 day ago$294.48k - $386.51k
...New Jersey, we are developing advanced cell therapies across a diverse array of technology... ...Early Clinical Development Team, for IND submission and the design, execution and... ...medical monitoring, safety reporting, regulatory documentation and interactions, and other...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Writer for Cell Therapy Submissions (Hybrid). Be the first to apply!
Related searches
- remote travel writer New Brunswick, NJ
- grant writer remote New Brunswick, NJ
- remote legal writer New Brunswick, NJ
- food regulatory New Brunswick, NJ
- regulatory New Brunswick, NJ
- regulatory contract New Brunswick, NJ
- regulatory scientist New Brunswick, NJ
- regulatory law New Brunswick, NJ
- therapy technician New Brunswick, NJ
- respiratory therapy supervisor New Brunswick, NJ