CMC Regulatory Writer: Drug Submissions & Compliance
ESR Healthcare
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 pharmaceutical sciences, along with experience in regulatory writing, demonstrating strong project management and collaboration skills. #J-18808-Ljbffr ESR Healthcare
- ...seeking an experienced Pharmaceutical CMC Writer in Paramus, New Jersey. The... ...preparing technical documents related to regulatory submissions for drug development and manufacturing. Responsibilities... ...documents, ensuring regulatory compliance, and collaborating with scientific...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... ..., and MAA applications. Compliance & Guidelines: Ensure documents...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
$170k - $190k
...Shinyaku Co., Ltd. In Japan Summary: CMC Regulatory Affairs develops and executes CMC... ...preparation, internal alignment, and submission logistics. Coordinate and oversee CMC... .../technical input for full regulatory compliance. Serve as the day-to-day CMC...RegulatoryTemporary workFor contractorsWork at officeFlexible hours- ...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,... ..., NDAs/BLAs/MAAs). Ensure compliance with ICH, GCP, FDA & EMA... ...are seeking a skilled Medical Writer to develop high-quality clinical... ...Plans (PIPs). New Drug Applications (NDAs), Biologics...RegulatoryShift work
$115k - $140k
Manager, Regulatory Operations Job Locations: US-NJ-Paramus ID: 2026... ...planning and delivery of regulatory submissions (IND, NDA, Agency Responses,... ...(Clinical, Nonclinical, CMC) to collect necessary... ...workflows can improve speed and compliance. Ability to explain technical...RegulatoryFull time$160k - $215k
...agencies, and health systems with drug formularies), in compliance with all relevant company policies.... ...sponsored studies (ISS), and supports ISS submissions through appropriate internal... ...appropriate communication with Medical, Regulatory, and Legal personnel within the...RegulatoryWork at officeLocal area$170k - $190k
...Japan Summary: Nonclinical Regulatory Affairs serves as the... ...scientific positions across submissions. The Associate Director/Director... ...support efficient global drug development. This is a hybrid... ...DMPK, clinical development, and CMC teams to ensure alignment of...RegulatoryTemporary workWork at officeFlexible hours- 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... ..., NDAs, BLAs, and MAAs. Ensure compliance with ICH, GCP, FDA & EMA guidelines....Regulatory
- ...Regulatory Submission Coordinator With minimal supervision, responsible for coordination and preparation... ...and clinical protocols for regulatory compliance to international/recognized standards... ...representatives from the Food and Drug Administration (FDA), Authorized...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
$17.5 - $30.2 per hour
...safety regulations including Food Safety and regulatory duties required in the department. Job Responsibilities Completes Order Writer training Replenishes products through... ...product. Follows and complies, or ensures compliance, with established procedures, including Weights...RegulatoryHourly payFull timePart timeSeasonal workImmediate startAll shiftsFlexible hoursNight shift- ...Director of Inspection Management/Quality Compliance will report to the VP and Head of... ...inspections. The Director also maintains regulatory intelligence to anticipate changes in global... ...plans, etc., and regulatory agency submissions, as applicable. Partners with key stakeholders...Regulatory
- ...Specialist Track and review manufacturing batch records to ensure compliance with regulatory requirements. Follows up with Manufacturing Technicians to... ...that could affect the safety, efficacy and quality of drug substance. Review batch record structure and recommend...Regulatory
- Position Medical Writer (Must Have EU MDR) Location Franklin Lakes, NJ Duration... ...writer is a pivotal role to ensure compliance with associated regulations and... ...quality study documentation that is submission‑ready for various regulatory agency and external distribution....RegulatoryContract workWork at office
- ...designated geographic region to ensure vehicle reliability, safety, regulatory compliance, and cost efficiency. This role partners closely with branch... ...protected by law. Brink's is also committed to providing a drug-free workplace. We are an Equal Opportunity Employer and...RegulatoryLocal area
$200k - $225k
...directing the company's general accounting, regulatory accounting, and management & services (... ...the integrity of accounting records, compliance with regulatory requirements, and the... ...required. Oversee the preparation and submission of annual regulatory reports and...RegulatoryFlexible hours$110k - $135k
...relevant regulations including FDA, ICH, local regulatory requirements and NS Pharma standard... ...documents, and patient Assure compliance of investigational sites with SOPs, FDA... ...cultural, global team environment and support drug development collaboration with global project...RegulatoryTemporary workWork at officeLocal areaFlexible 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
$24.81 - $41.35 per hour
...center operations while adhering to all compliance and risk policies and procedures. Coach... ...risk by ensuring the team's adherence to regulatory standards while exercising sound judgment... ...medical plans with prescription drug coverage; flexible spending account or health...RegulatoryHourly payFull timeTemporary workWork experience placementLocal areaWork visaFlexible hours- ...Specialist, Trade Compliance L3Harris is currently seeking a Specialist Technical Trade... ...Requests (CCR/CCATs) for submission to Directorate of Defense Trade Controls... ...teammates to enhance continuous learning, regulatory knowledge, and improved best practices...RegulatoryWork at office
- ...propositions, data reporting capabilities, and compliance advantages. Manage the entire sales... ...updates. Stay up to date on emerging drugs, testing methodologies, reimbursement changes... ...to work independently. Knowledge of regulatory and compliance requirements within addiction...RegulatoryContract workImmediate start
- ...ability to conduct various audits are essential. This role involves preparing audit plans, tracking corrective actions, and supporting regulatory inspections. A Bachelor’s degree in a relevant field and ASQ Certification are required. #J-18808-Ljbffr GlobalchannelmanagementRegulatory
$45.52 - $56.9 per hour
...System in Paramus, NJ, is seeking a Radiologic Technologist to provide patient care tasks and perform various procedures in compliance with regulatory requirements. This role requires certification and formal training in radiologic technology, and it offers competitive...RegulatoryHourly pay$120k - $130k
The City of Lincoln is seeking a Compliance Officer to join SpecialtyRx, a leading pharmacy... ...role involves maintaining compliance with regulatory agencies, conducting inspections, and... ...00.00 annually. Join us in transforming drug care and ensuring quality across our locations...RegulatoryFull time- ...in Hackensack, NJ seeks an experienced Regulatory Affairs Specialist - Dairy to lead regulatory... ...American dairy products, ensuring compliance while enabling innovation. You will... ...regulations, review labeling, manage regulatory submissions, and support product launches. Hybrid...Regulatory
- ...guidance to Team Leaders in operations including profitability, expense control, inventory, buying, merchandising, labor and regulatory compliance. The position requires willingness to take a position in different stores within 35 miles or one hour commute from home, and...Regulatory
- ...to delivering high-quality, affordable drug products through disciplined execution and... ...supports the safety, reliability, and compliance of products relied upon downstream. We value... ..., data, and documentation meet GMP and regulatory expectations. This role works closely...Regulatory
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