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
- ...ID31574962Reference25-04573 Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for... ...Manufacturing, and Controls (CMC) deliverables across drug development programs. Key Responsibilities: Author...RegulatoryWork at office
$60 per hour
...Medical Writer Position The Medical Writer will primarily work on the... ...), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications... ...for ongoing and future submissions depending upon the scope of the...RegulatoryContract workWork at office- SK Life Science, Inc. in New Jersey seeks a Regulatory Operations Manager to drive regulatory submissions (IND/NDA) across development programs. You will coordinate cross-functional teams and ensure alignment with eCTD standards and health authority guidelines. The role...Regulatory
- ...Medical Writer II We believe that great healthcare is an essential safeguard of human... ...execution of clinical, scientific, and regulatory documents and presentations for internal... ...accordance with MEDDEV 2.7/1 Rev 4 and MDR Submissions. Working knowledge of medical device...RegulatoryFlexible hoursShift work
$78k - $85k
...seeking a highly skilled Technical Writer/Editor to support the US Army... .... This role requires an expert-level understanding of... ...background in Army doctrine, strict regulatory standards, and complex... ...estimates to the COR for CASCOM G-3 submission. Gather annual historical...RegulatoryContract workWork at officeLocal area- ...night-shift coverage. The role involves providing comprehensive patient care across diverse age groups, adhering to licensure and regulatory requirements, and collaborating with a multidisciplinary team. Required are a Bachelor's degree in Nursing, an active New Jersey...RegulatoryNight shift
- 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
- ...budgets, quality standards, regulatory requirements, and ICH-... ...including radioactive drug supply, nuclear... ...and timely regulatory submissions. The Director / Senior... ...Affairs, Medical Affairs, CMC, Drug Supply, Quality Assurance... .... Ensure that local experts, country leads, site...RegulatoryLocal area
- ...We are hiring for Job Tilte: Customs Entry Writer / Data Entry & PGA Specialist Location: Moonachie, NJ Job Type: Full... ...where youll play a key role in ensuring smooth import operations, regulatory compliance, and outstanding service to our clients. Key...RegulatoryFull timeImmediate start
- American Shipping Company in Moonachie, NJ, is seeking an Entry Writer / Data Entry & PGA Specialist to support import operations and regulatory compliance. The role emphasizes accurate data entry, HTS code research, FDA PGA handling, and coordination with Customer Service...Regulatory
- ...clearance, DEA Controlled Drug experiences, etc.Manage and processing of CMC Team project invoices... ....Assist and support Regulatory Affairs (RA) to provide... ...any documents for their submissions (US and Global).Assist... ...interpret financial reports.Expert technical skills, good...RegulatoryContract workWork at office
- ..., and grow internationally. Role Description The Customs Entry Writer is a full-time role based in Secaucus, NJ in a hybrid work arrangement... ...for imports, ensuring compliance with U.S. Customs and other regulatory agencies. Day-to-day tasks include classifying merchandise,...RegulatoryFull timeWork from homeWorldwide
- ...Overview: We are seeking a meticulous and experienced Technical Writer to join our team. The primary responsibility of this role will... ...regular basis to reflect changes in procedures, policies, and regulatory requirements. Work closely with the Compliance Director to review...RegulatoryWork at office
- ...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
$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...RegulatoryFull timeWork at officeLocal area$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- ...will set strategic operations, oversee trial execution, and coordinate with Regulatory Affairs, Medical Affairs, Drug Supply, and QA to ensure quality, safety, and on-time regulatory submissions. Responsibilities include budget planning, risk management, CRO oversight,...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- ...currently looking for an experienced Quality Assurance Technical Writer in Ridgefield, New Jersey (NJ) to work for an innovative and... ...GMP, Batch Record, Manufacturing, GDP, cGMP, Clinical Manufacturing, Regulatory Review, #LI-ONSITE #LI-DF1 #J-18808-Ljbffr Piper CompaniesRegulatoryWork at office
- ...to ensure compliant, efficient import of products into the United States. You will support import execution, broker management, regulatory coordination, and trade program administration. Collaborate with Regulatory Affairs and internal partners to classify HTS, address...Regulatory
$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 timePart timeWork experience placementSeasonal workImmediate startAll shiftsFlexible hoursNight shift- ...Scientific Writer PsychoGenics is a preclinical CRO with expertise in central nervous system (CNS) and orphan disorders. Our mission... ...SBIR/STTR), DoD, and foundation grants. Familiarity with FDA drug development pathways for pain therapeutics. Familiarity with...Full timeContract workTemporary workPart timeRemote work
- Laborie, a global medical device company, seeks a Medical Writer II to develop and execute clinical, scientific, and regulatory documents for PMS, PSURs, CERs, and PMCFERs in accordance with evolving international standards and Laborie SOPs. You will collaborate with cross...Regulatory
$110k - $135k
...for firm attorneys, including submissions, abstracts, biographies, and... ...healthcare law, reimbursement, regulatory matters, or another regulated... ..., or other subject-matter experts. Salary Range $110,000–$135,0... ...disorder (not currently using drugs illegally) Autoimmune disorder...RegulatoryContract workFor contractorsFor subcontractorWork at office$110k - $135k
...for firm attorneys, including submissions, abstracts, biographies, and... ...healthcare law, reimbursement, regulatory matters, or another regulated... ..., or other subject-matter experts. Salary Range $110,000–$135,0... ...disorder (not currently using drugs illegally) Autoimmune disorder...RegulatoryContract workFor contractorsFor subcontractorWork at office- ...building systems across plumbing, electrical, heating, and cooling. You will help manage preventive maintenance and ensure safety and regulatory compliance in daily operations. The role emphasizes energy efficiency, reliable system performance, and teamwork within CBRE's...Regulatory
- ...Payroll & Benefits Manager to oversee multi-state payroll and firm-wide benefits administration. You will ensure payroll accuracy, regulatory compliance, and process improvements while partnering with HR, Finance, and leadership to deliver an exceptional employee...Regulatory
$54 - $60 per hour
...-investigators, clinical research nurses, regulatory specialists, and study patients, supporting trial feasibility, regulatory submissions, patient recruitment and education, and accurate... ...to patients and caregivers on drug administration and other medical information...RegulatoryContract workTemporary workLocal area
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