Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory CMC Writer — Drug Submissions Expert in Paramus, NJ vacancy
  • 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

    ESR Healthcare

    Paramus, NJ
    1 day ago
  • 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

    5 Star Recruitment

    Paramus, NJ
    1 day ago
  •  ...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... 
    Regulatory
    Work at office

    Katalyst Healthcares & Life Sciences

    Paramus, NJ
    1 day ago
  • $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... 
    Regulatory
    Contract work
    Work at office

    Allen Spolden

    New Milford, NJ
    19 hours ago
  • 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

    SK Life Science, Inc.

    Paramus, NJ
    3 days ago
  •  ...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... 
    Regulatory
    Flexible hours
    Shift work

    Laborie Medical Technologies

    Orangeburg, NY
    1 day ago
  • $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... 
    Regulatory
    Contract work
    Work at office
    Local area

    Hive Group, LLC

    Fort Lee, NJ
    9 hours ago
  •  ...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... 
    Regulatory
    Night shift

    01 The Valley Hospital

    Paramus, NJ
    3 days ago
  • 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

    SK Life Science

    Paramus, NJ
    2 days ago
  •  ...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... 
    Regulatory
    Local area

    SK Life Science, Inc.

    Paramus, NJ
    4 days ago
  •  ...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... 
    Regulatory
    Full time
    Immediate start

    BrezQ

    Edgewater, NJ
    2 days ago
  • 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

    American Shipping Company

    Moonachie, NJ
    2 days ago
  •  ...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... 
    Regulatory
    Contract work
    Work at office

    5 Star Global Recruitment Partners

    Paramus, NJ
    1 day ago
  •  ..., 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,... 
    Regulatory
    Full time
    Work from home
    Worldwide

    Logfret - Your international logistics and supply chain part...

    Secaucus, NJ
    1 day ago
  •  ...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... 
    Regulatory
    Work at office

    United Merchant Services

    Hackensack, NJ
    2 days ago
  •  ...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... 
    Regulatory
    Contract work

    Hudson Regional Health

    Secaucus, NJ
    2 days ago
  • $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... 
    Regulatory
    Full time
    Work at office
    Local area

    SK Life Science, Inc.

    Paramus, NJ
    4 days ago
  • $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... 
    Regulatory
    Full time

    SK Life Science

    Paramus, NJ
    19 hours ago
  •  ...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

    SK Life Science, Inc.

    Paramus, NJ
    4 days ago
  • $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... 
    Regulatory
    Hourly pay
    Full time
    Part time
    Seasonal work
    Immediate start
    All shifts
    Flexible hours
    Night shift

    Whole Foods Market IP. L.P.

    Edgewater, NJ
    1 day ago
  •  ...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 Companies
    Regulatory
    Work at office

    Piper Companies

    Ridgefield, NJ
    3 days ago
  •  ...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

    bdx

    Franklin Lakes, NJ
    2 days ago
  • $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... 
    Regulatory
    Hourly pay
    Full time
    Part time
    Work experience placement
    Seasonal work
    Immediate start
    All shifts
    Flexible hours
    Night shift

    Whole Foods

    Montclair, NJ
    4 days ago
  •  ...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 time
    Contract work
    Temporary work
    Part time
    Remote work

    PsychoGenics

    Paramus, NJ
    4 days ago
  • 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

    Laborie

    Orangeburg, NY
    3 days ago
  • $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... 
    Regulatory
    Contract work
    For contractors
    For subcontractor
    Work at office

    Gottlieb and Greenspan

    Fair Lawn, NJ
    4 days ago
  • $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... 
    Regulatory
    Contract work
    For contractors
    For subcontractor
    Work at office

    Gottlieb and Greenspan

    Fair Lawn, NJ
    4 days ago
  •  ...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

    CBRE

    Saddle Brook, NJ
    3 days ago
  •  ...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

    Talent Acquisition LLC

    Hackensack, NJ
    2 days ago
  • $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... 
    Regulatory
    Contract work
    Temporary work
    Local area

    Actalent

    Paramus, NJ
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory CMC Writer — Drug Submissions Expert. Be the first to apply!