Senior Regulatory CMC Writer for Biologics (Remote)
TG Therapeutics, Inc.
- Remote job
TG Therapeutics, Inc. is seeking an experienced Regulatory CMC consultant with BLA writing expertise to provide hands-on authoring and submission support for biologics. The role focuses on Module 3 and related Quality content, collaborating with cross-functional teams to deliver regulator-ready CMC narratives and respond to FDA requests, while maintaining rigorous document control and traceability. This remote engagement requires excellent scientific writing, strong regulatory knowledge of FDA #J-18808-Ljbffr TG Therapeutics, Inc.
- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the Senior Director, Biologics CMC will provide... ...manufacturing, analytical development, quality, regulatory CMC, and external manufacturing. Because we...Remote workSeniorRegulatoryFull time
- Scorpion Therapeutics is seeking a Senior Associate, Regulatory CMC to lead strategy, compliance, and submissions for biologics and cell therapy products. You will prepare IND/IMPD... ..., Manufacturing, and R&D teams in a fully remote setup. Applicants should have 5+ years in...Remote jobSeniorRegulatory
$132k - $172k
...for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...lifecycle management activities for biologic products, with a strong focus on late... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workSeniorRegulatoryFull timeTemporary workWorldwide$55 - $75 per hour
...genetics and molecular biology, we develop medicines... ...is a Contract role- Remote can live anywhere in... ...- $55 to $75hour The Senior Medical Writer applies advanced documentation... ...study results for regulatory submissions and... ...nonclinical development, CMC, PK, PD, and antibody...Remote workSeniorRegulatoryFull timeContract workFor contractorsWorldwideShift work$132k - $151k
Principal Medical Writer - CMC Focus page is loaded## Principal Medical... ...:****Job Overview:**Regulatory Writers prepare high-quality... ...Flexible, inclusive culture - 70% remote workforce, 66% women-led teamsLearn... ..., gene/cell therapy, biologics, small molecule, manufacturing...Remote workRegulatoryLocal areaWorldwideFlexible hours- ...Clinical Regulatory Document Specialist Company Overview Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device... ...within the medical/biomedical industry. BS or MS degree in biological science, epidemiology, engineering, statistics, or other science...Remote workSeniorRegulatoryInterim roleWorldwide
- ...approach to complex trial data and regulatory submission challenges. With a... .... This is a full-time, remote position. Roles and Responsibilities... ..., regulatory operations, and CMC. Demonstrated ability to... ...in pharmacology, toxicology, biology or chemistry, or related field...Remote workSeniorRegulatoryFull time
$200k - $290k
...highly self-motivated Director/Senior Director of CMC Quality Operations to join... ...Operations Location: Remote (U.S.) What You'll Do Faeth... ...development of clinical assets and regulatory submissions. This position... ...techniques in support of biologic and small molecule...Remote workSeniorRegulatoryContract workFlexible hours$230k - $270k
...Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory... ...in South San Francisco and may be remote up to 2 days per week.... ...Manufacturing Practices (GMP), drug and biologics development regulations and guidelines...Remote workSeniorRegulatoryFull timeContract workInternshipLocal area2 days per week- Role Senior Manager, Biologics CMC Project Management within Incyte's Tech Ops Global Biologics Development group, leading cross-functional project... ...in CMC project activities and understanding of regulatory requirements. Education BS/MS/PhD in Biological Sciences...SeniorRegulatory
- Veristat is seeking a Principal Medical Writer with CMC focus for remote work. You will lead authoring for complex regulatory submissions, mentor junior writers, and drive document quality across modules, including Module 3 and 2.3, ensuring alignment with global health...Remote jobRegulatory
- Travere Therapeutics seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. The role oversees content integration, timelines, and regulatory messaging across multiple...Remote jobRegulatory
- ...focused on rare diseases, seeks a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego with extensive CTD Module 2/3... .... The role leads CMC submission strategy, collaborates with Regulatory Affairs and SMEs, and directs preparation of high-quality...Remote jobRegulatory
- ## Job Details: Senior Manager, Medical/Regulatory WriterFull details of the job.| | ||... ...Manager, Medical/Regulatory Writer || | VN831 || | Full Time... ..., MD, Radnor, PA, Remote, US || | Regulatory Affairs... ...industry (preferably with biologics), experience in the preparation...Remote workSeniorRegulatoryFull timeContract work
- Principal Medical Writer At ICON Strategic Solutions... ...of high-quality regulatory and clinical documents... ...applications for new biologics and drugs The position... ...includes all duties of a Senior Medical Writer, as well... ...preferred. #LI-NR1 #LI-Remote What ICON can offer...Remote workSeniorRegulatoryWorldwideFlexible hours
- ...clinical-stage biotech company, seeks a Director of CMC Project Management to lead end-to-end CMC program execution for biologics. You will partner with the CMC Lead to align... ..., manufacturing, supply chain, quality, and regulatory functions. The role emphasizes tight...Remote jobRegulatory
$150k - $170k
...a talented, motivated Senior Manager to join our Portfolio... ...Technology, Clinical, Regulatory, and other development... ...with an emphasis on CMC knowledge and the ability... ...(US-based, west coast remote may be considered for... ...preferred; experience with biologics or complex modalities...Remote workSeniorRegulatoryFull timeWork at officeLocal area- Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and cross-functional... ...engagement, and global submissions. Location is hybrid/remote in Bedford, MA, with a move to Waltham; travel minimal;...Remote jobSeniorRegulatory
$65 - $75 per hour
...seeking a highly motivated Senior Scientist, Computational Biology to join our team. The... ...translational, clinical, and regulatory work — from multi-platform... ...hybrid onsite 3 days a week or remote with travel to Allogene’s... ...Regulatory and CMC support Generate analysis...Remote workSeniorRegulatoryHourly payTemporary workFor contractorsInternshipLocal area3 days per week- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC activities from IND through commercialization. The role spans global submissions, Health Authority interactions, and lifecycle management...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will collaborate with Development, Manufacturing, Quality, and Regulatory Operations...Remote jobSeniorRegulatory
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory guidance to biotechnology and pharmaceutical clients from development through commercialization and lifecycle management. The role leads global...Remote jobSeniorRegulatory
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and...Remote jobSeniorRegulatory
- ...clinical-stage oncology company, seeks a Director/Senior Director of CMC Quality Operations. This remote US role collaborates across CMC, Technical Operations... ...manage stability programs, method transfer, and regulatory reporting, ensuring cGMP compliance, robust data analysis...Remote jobSeniorRegulatory
- ...Scientific community. We are currently looking for a REMOTE Associate Director Medical Writer to work for a leading San Diego biotech company. Responsibilities... ...with Clinical Development, Biostatistics, and Regulatory teams to translate complex data into clear, high-...Remote workSeniorRegulatoryWork at office
- ...inVentiv Health Commercial LLC is seeking a Sr Medical Writer Publications to lead the completion of medical writing deliverables remotely. This role involves managing writing activities, ensuring adherence to regulatory standards, and mentoring junior writers. The ideal...Remote workSeniorRegulatory
$132k - $151k
...looking for a Principal Medical Writer - CMC Focus based in United States . This is a senior regulatory writing role focused on... ...will work across areas such as biologics, vaccines, gene and cell therapy... ...capabilities. Benefits Remote Work: Fully remote working...Remote jobRegulatoryFull timeLocal areaFlexible hours$189 per hour
...CA - For positions listed as San Diego/Remote, our preference is for candidates who are... ...:The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for the... ..., and Controls (CMC) documentation for regulatory submissions, including Biologics...Remote workRegulatoryContract workWork experience placementWork at officeLocal area2 days per week$120k - $200k
...and communities.The RoleFalcon Writer is Veeva's AI authoring... ...directly with medical writing, regulatory, and clinical teams at customer... ...customer discovery and align senior stakeholders and cross-functional... ...bonus and/or stock bonus.#LI-Remote#LI-MidSeniorVeeva’s headquarters...Remote workSeniorRegulatoryWork at officeLocal areaWork from home3 days per week- ...what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on... ...flexible working arrangements, remote work options, and tax assistance...Remote workSeniorRegulatoryHourly payWork at officeLocal areaRelocation packageFlexible hours
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