Remote Analytical SME & CMC Writer for Regulatory Submissions
Sigma Systems
Sigma Systems, Inc. is looking for an experienced Analytical SME & CMC Technical Writer to join their remote team. This role requires deep expertise in drug substance (DS) and drug product (DP) development, particularly in analytical development and quality control. The successful candidate will aid in regulatory submissions and collaborate with internal and external teams to ensure compliance and scientific robustness in documentation. An advanced degree and significant experience in the field are preferred. #J-18808-Ljbffr
$50.72 - $55.72 per hour
...Analytical Sme And Cmc Technical Writer Pay Range $50.72/hr - $55.72/hr Job Overview We are seeking an experienced Analytical Subject... ...formulations. ~ Demonstrated working experience in regulatory submissions. ~ Familiarity with GMP and regulatory guidelines...Remote workRegulatoryWork experience placement$57 - $58.45 per hour
job summary: Are you a seasoned CMC expert looking for a high-impact,... ...leader is seeking a remote Analytical SME & CMC Technical Writer. This fully remote position requires... ...analytical strategies and author critical regulatory submissions. location: Telecommute job...Remote workRegulatoryHourly payContract workTemporary workWork experience placementFlexible hours$45 - $53.33 per hour
...Job Title: Analytical SME & CMC Technical Writer Location: Ridgefield, CT Type: Contract Compensation... ....33/hr Contractor Work Model: Remote – offsite Hours: 40.0... ...the Veeva RIM system to support regulatory submission activities Author, review, and...Remote workRegulatoryContract workFor contractorsLocal area$55 - $59 per hour
...We are seeking an experienced an Analytical SME & CMC Technical Writer to support drug substance and drug... .... Location: REMOTE (Candidates must work East Coast... ...CTD Module 3 content. Support regulatory submissions (IND, CTA, NDA, MAA) and health authority...Remote workRegulatoryContract work- WillHire is seeking an experienced Analytical Subject Matter Expert and CMC Technical Writer to support drug substance and product development programs.... ...lead analytical development initiatives, manage regulatory submissions, and collaborate with internal and external...Regulatory
- 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
- ...Charleston, SC is seeking a Nonclinical Writer to develop and manage nonclinical... ...ideal candidate will have 2+ years of regulatory writing experience along with strong analytical and communication skills. This full-time, remote role offers the opportunity to work in...Remote workRegulatoryFull time
- ...organization is seeking a technical writer to develop and manage nonclinical documents. This full-time remote position requires a BS in... ...fields, with a minimum of 2 years in regulatory writing. Candidates should possess strong analytical skills and familiarity with regulatory...Remote workRegulatoryFull time
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory... ...strategies for drug approvals and submissions. Candidates should have extensive experience... .... The position is hybrid, with remote work and occasional onsite requirements...Remote jobRegulatory- ...scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ...biostats, regulatory operations, and CMC Demonstrated ability to lead others... ..., persuasion, collaboration, and analytical judgment Organizational expert within...Remote workRegulatory
$130.8k - $209.4k
...alignment with program goals, regulatory expectations, and... ...for regulatory submissions, responses, and technical... .... Collaborate across Analytical Development, Quantitative... ...at the Moderna site. Remote work is not eligible.... ...working in cross‑functional CMC teams within a...Remote workRegulatoryPermanent employmentFull time- ...clinical research organization is seeking a Regulatory Writer to manage and develop technical nonclinical documents. This full-time, remote position requires at least 2 years of... ...in the pharmaceutical industry, strong analytical skills, and proficiency in MS Office. Ideal...Remote workRegulatoryFull time
$152.7k - $218.13k
...Principal Scientist, CMC Analytical Development Remote Akero Therapeutics, a Novo Nordisk company, is... ...development leading to licensure application submission. The successful candidate will work... ...of technical reports needed for regulatory filings and participation in the...Remote workRegulatoryWork at officeFlexible hours- ...A leading biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...Remote workRegulatory
- ...healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will have... ...writing experience, particularly in regulatory submissions. This role offers a competitive salary and a variety...Remote workRegulatoryFlexible hours
- ...Our client is seeking an experienced Regulatory CMC Technical Writer to support the preparation of Module... ...sections for a biologics regulatory submission. The ideal candidate will combine... ...source documents (process development, analytical, characterization reports) into...RegulatoryLocal area2 days per week3 days per week
$50 - $60 per hour
...Job Title: Regulatory CMC Technical Writer Location: Hampton, New Jersey (Hybrid – onsite 2–3 days per... ...for a biologics regulatory submission. The successful candidate will possess... ...documents, including process development, analytical, characterization, and manufacturing...RegulatoryHourly payContract workWork at officeLocal area2 days per week3 days per week- ...JOB TITLE: Technical writer Location: New Brunswick... ...for delivering CMC documentation (dossier... ...documents) to support the regulatory strategy for a late-stage... ...on timelines for submissions. The position interfaces... ...Process Development, Analytical Development, Cell Therapy...RegulatoryWork at officeLocal area
$33.03 - $41.95 per hour
...Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage... ...Management Office and will support regulatory submission activities, dossier preparation... ...with Process Development, Analytical Development, Cell Therapy Technical...RegulatoryHourly payContract workWork at officeLocal areaMonday to Friday- ...Job Title: Sme - Financial And It Modeling & Analytics Location(s): Washington, DC (Remote) Skills: Mortgage Cashflow Models, complex models, and analytical tools... ...usage goals and objectives. • Stay abreast of regulatory requirements as well as internal standards...Remote workRegulatoryWork experience placement
- ...seeking a Senior Principal Scientist (Sr. Director level) in Regulatory Affairs CMC, focused on dry powder inhaler combination products. This... ...coordination. Benefits include a comprehensive package and a potential remote work option for qualified candidates. #J-18808-Ljbffr Merck...Remote workRegulatory
- ...research organization is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents. This remote, full-time role involves close collaboration... ...teams and requires strong writing skills, regulatory knowledge, and the ability to navigate...Remote workRegulatoryFull time
- ...Insurance Analytics SME Chicago, Illinois, United States About the Job Our client... ...experience in the Insurance industry. This is a remote role with the potential to become... ..., etc. Understand the insurance regulatory environment and market across insurance...Remote workRegulatory
$50k - $75k
...Customs Entry Writer - On-site Springfield, NJ... ...and qualifications) Remote Option: No About Us... ...coordination and entry summary submissions Maintain clear... ...Suite. Strong analytical and problem-solving skills... ...to navigate complex regulatory environments. Benefits...Remote workRegulatoryWork at office- ...clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional... ...writing skills and familiarity with GLP and ICH guidelines are essential for this remote position. #J-18808-LjbffrRemote workRegulatory
- ...ZS. ZS's Insights & Analytics group partners with clients... ...in the pharmaceutical CMC development area for... ...attributes, and regulatory milestones across pharma... ...CMC related regulatory submission requirements * Ability... ...flexibility to work remotely two days a week is also...Remote workRegulatoryLocal areaImmediate startWorldwideFlexible hours2 days per week3 days per week
- ...Job Location: 100% Remote Duration: 6+ months (with... ...EliteQuests is seeking a Senior/SME Workday Report Writer Consultant for a 6+ month... ...troubleshooting and analytical skills . ~ Self-... ...tracking and collaboration. Submission Requirements: Updated...Remote jobContract work
- Associate Director or Director CMC Regulatory Affairs Job Title: Associate... ...VP of Regulatory Location: Remote or Onsite Position Summary:... ..., supporting regulatory submissions, and serving as the regulatory... ...functionally with process development, analytical development, manufacturing,...Remote workRegulatoryContract work
$20 - $26 per hour
...documentation of claim actions, appeal submissions, and outcomes Identify... ..., payer guidelines, and regulatory requirements including HIPAA... ...required Strong analytical and critical thinking skills... ...metrics-driven environment Remote work experience in a structured...Remote workRegulatoryPermanent employmentFull timeWork experience placement- ...Manufacturing & Controls (CMC) and Devices... ...leads the execution of regulatory CMC investigational, registration... .... Strong analytical or process understanding... ...of robust and accurate submissions Develops constructive... ...Takeda's Hybrid and Remote Work policy. #LI-Hybrid...Remote workRegulatoryWorldwide
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