Regulatory CMC Writer — Drug Submissions Expert
5 Star Recruitment
A leading recruitment firm is seeking an experienced Pharmaceutical CMC Writer in Paramus, New Jersey. The candidate will play a critical role in preparing technical documents related to regulatory submissions for drug development and manufacturing. Responsibilities include authoring clinical documents, ensuring regulatory compliance, and collaborating with scientific teams. Candidates should possess a relevant degree and prior experience in pharmaceutical or regulatory writing. #J-18808-Ljbffr 5 Star Recruitment
- A leading company in pharmaceuticals is seeking a CMC Writer in Paramus, NJ. This role involves authoring regulatory documents such as NDA and MAA applications, ensuring compliance with FDA and EMA guidelines. The ideal candidate will have a background in chemistry or...Regulatory
- A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality... ...affairs teams, and manufacturing experts to gather accurate data....Regulatory
- MillenniumSoft Inc. is seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. You will develop clinical and regulatory documents, coordinate with cross‑functional...Regulatory
- SK Life Science Inc. is seeking a Regulatory Operations Manager to lead planning and delivery of regulatory submissions (IND, NDA) and support processes for compliant, timely filings... ...coordination with Clinical, Nonclinical, and CMC teams to meet health authority requirements....Regulatory
- ...in the pharmaceutical industry. ~3 years of independent/lead authoring experience (authoring regulatory documents supporting clinical trials and regulatory submissions). ~ Experience with Veeva RIM (authoring/review platform) required. ~ Knowledge or Experience...Regulatory
- ...Responsibilities Develop clinical & regulatory documents (CSRs, CSPs, IBs, ICFs, CTD Modules... ...timelines. We are seeking a skilled Medical Writer to develop high-quality clinical and... ...Pediatric Investigation Plans (PIPs). New Drug Applications (NDAs), Biologics License Applications...RegulatoryShift work
- Job Title: CMC Writer / Project Manager Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. Responsibilities Develop clinical & regulatory documents, including...Regulatory
$17.5 - $30.2 per hour
...ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Job Responsibilities Completes Order Writer training Replenishes products through proper buying procedures. Orders perishable and/or...RegulatoryHourly payFull timePart timeSeasonal workImmediate startAll shiftsFlexible hoursNight shift- Position Medical Writer (Must Have EU MDR) Location Franklin Lakes, NJ Duration... .... Serve as a subject matter expert on clinical aspects of Technical documentation... ...quality study documentation that is submission‑ready for various regulatory agency and external distribution....RegulatoryContract workWork at office
$170k - $190k
...Shinyaku Co., Ltd. In Japan Summary: CMC Regulatory Affairs develops and executes CMC... ...material preparation, internal alignment, and submission logistics. Coordinate and oversee... .... Manage external CMC regulatory expert consultations (consultants/contractors)...RegulatoryTemporary workFor contractorsWork at officeFlexible hours- SK Life Science seeks a Regulatory Operations Manager to lead planning and delivery of regulatory submissions (IND, NDA) for new products in Paramus, NJ. You will ensure eCTD standards, coordinate cross-functional content plans, and support regulatory maintenance throughout...Regulatory
- ...-time radiologic technologist to perform routine and advanced radiographic procedures, including mammography, in compliance with regulatory standards. The ideal candidate is a graduate of an accredited Radiology program and holds ARRT certification as a Mammo Tech. We...RegulatoryFull timeDay shift
- ...Office, ARIBA, CTM inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP... ...expiration dating for investigational drug products is valued. Understanding of... ...experiences, etc. Manage and processing of CMC Team project invoices and internal...RegulatoryContract workWork at office
- ...Title: Technical Writer Location: Franklin Lakes, NJ Contract Term: 12+ Months Shift/Hours: 1st Shift ( 8-9am to 4-5pm... ...User Information Development, R&D, Marketing, Quality, Medical, Regulatory and plant production teams, and will lead or participate in...RegulatoryContract workH1bWork at officeShift workDay shift
- ...high-level legal and administrative support. The role includes managing legal documents, conducting legal research, and ensuring regulatory compliance. Candidates should have at least three years of paralegal experience and possess a paralegal certificate or relevant degree...RegulatoryContract work
$115k - $140k
Manager, Regulatory Operations Job Locations: US-NJ-Paramus ID: 2026-1998 Category: Regulatory... ...the planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others)... ...teams (Clinical, Nonclinical, CMC) to collect necessary documentation. Participates...RegulatoryFull time- MillenniumSoft Inc is seeking a Technical Writer located in Franklin Lakes, NJ. This role involves developing, revising, and implementing... ...documentation for BD products, ensuring compliance with regulatory guidelines. The Technical Writer will collaborate across teams,...RegulatoryWork at office
- ...seeks a senior quality leader to develop and maintain a robust QMS aligned with AS9100, ISO 9001, and Nadcap, guiding audits and regulatory compliance across aerospace programs. You will oversee CMM inspections, GD&T, root-cause analysis, RCCM/CAPA, FAI and PPAP/APQP,...Regulatory
- ...financial accounting functions for a multinational group. The role oversees AP/AR, GL, payroll, monthly and year-end closings, and regulatory compliance. Ideal candidates have 15-20 years of experience, CPA preferred, and strong U.S. GAAP knowledge. English and Korean...Regulatory
- Laborie in Orangeburg, NY is seeking a Medical Writer II to develop clinical, scientific, and regulatory documents. This role involves collaborating with teams and conducting literature searches for product support. Candidates should have a bachelor's degree in a scientific...Regulatory
$160k - $215k
...maintaining relationships with key CNS experts and building a well‑informed... ..., and health systems with drug formularies), in compliance... ...(ISS), and supports ISS submissions through appropriate internal... ...communication with Medical, Regulatory, and Legal personnel within the...RegulatoryWork at officeLocal area$170k - $190k
...Summary: Nonclinical Regulatory Affairs serves as the... ...scientific positions across submissions. The Associate... ...regulatory teams, and external experts (including KOLs),... ...support efficient global drug development. This is... ...development, and CMC teams to ensure alignment...RegulatoryTemporary workWork at officeFlexible hours- ...team. This role involves overseeing claims staff, ensuring accurate Medicaid and Medicare claims adjudication, and compliance with regulatory standards. The position is in-office, located in Clifton, New Jersey, 5 days a week. The ideal candidate has over 5 years of...RegulatoryWork at office
- ...Regulatory Submission Coordinator With minimal supervision, responsible for coordination and preparation of document packages for regulatory... ...in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities...RegulatoryWork at office
- ...Regulatory Affairs Manager Mindlance Clinical has been providing scientific and clinical research staffing and... ...supporting a successful study from the inception of drug development planning to regulatory submissions to market, we understand it is the talent and...RegulatoryPermanent employmentFull time
- ...Clinical Study Manager Manages the progress of assigned studies by tracking regulatory/IRB submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution. Organize delivery of investigational product...Regulatory
- ...findings from audits and inspections. The Director also maintains regulatory intelligence to anticipate changes in global requirements and... ..., risk management plans, etc., and regulatory agency submissions, as applicable. Partners with key stakeholders, including Clinical...Regulatory
- ...essential for this role. Research skills: Must be skilled in conducting research and gathering information from subject matter experts to ensure accuracy in their documentation. Attention to detail: Attention to detail is crucial to ensure accuracy, consistency...
- ...Medical and Trade Institute (AMTI) is seeking an experienced Grant Writer to support the expansion of workforce, healthcare, and criminal... ...Technician, EKG, and criminal justice pathways. Manage submission timelines and post-award requirements when applicable. Required...Hourly payContract workPart timeRemote workFlexible hours
$17.5 - $30.2 per hour
...and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Responsibilities Purchases and replenishes food for preparation through proper buying...RegulatoryHourly payFull timeWork experience placementSeasonal workImmediate startAll shiftsFlexible hoursNight shift
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