Regulatory Submissions Specialist - eCTD & FDA Expert
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records, enabling timely submissions. The role requires strong communication skills and 5+ years in pharma regulatory affairs, with 3–4 years in regulatory operations. Competitive benefits and a robust team environment are offered. #J-18808-Ljbffr Breckenridge Pharmaceutical
- ...Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate...SuggestedFlexible hours
- Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing... ...document management and coordinates eCTD modules. The ideal candidate has a... ...operations experience, with expert knowledge of Health Authority procedures...Suggested
$45.66 per hour
...disease. Position Summary The Specialist II, Regulatory Documentation reports to the Director... ...of Electronic Common Tech Document (eCTD) modules. Essential Functions Create... ...for reports, assessments, regulatory submissions, letters, etc. Format and compile...SuggestedHourly payTemporary workMonday to FridayFlexible hours$117k - $120k
...Job Description AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory...SuggestedFor contractorsLocal area$115k - $135k
...the world. Responsibilities Publishes US Regulatory Submissions to the Food and Drug Administration:... ...PADERS, etc. on time in accordance with eCTD submission requirements. Works with the... ...templates that are fully compliant with FDA and ICH document requirements....SuggestedWork at officeFlexible hours- ...world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-... ...supplements in compliance with FDA requirements. Author relevant eCTD sections using company templates and...
- OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate... ...multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs,...Remote job
$32.5 - $36 per hour
...Description Overview\n Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States. This unique opportunity combines tax expertise,...Local area$28.36 per hour
...our community as well as globally. This role will ensure Berje's compliance with all Regulatory Standards globally. You will support the preparation, organization, and submission of regulatory documentation related to the approval and compliance of flavor and fragrance...Local area- ...Senior Regulatory Affairs SpecialistOrganOx is a commercial stage organ technology company... ...regions.The Senior Regulatory Affairs Specialist is responsible for leading and supporting... ...and process changes, and prepares submissions and other regulatory deliverables for the...
- ...monitored.We are looking for a Periodic Reports Expert to join our Global Periodic Reports Team and play a critical role in ensuring regulatory compliance, driving scientific rigor,... ...ensure timely and compliant regulatory submissions.Author and participate in health...Work at office
- ...Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, INDs, IDEs and PMAs) for... ...PMA Supplements, etc.) for submission to the FDA and Health Canada. · Interfacing with the FDA...For subcontractorRemote workFlexible hours
- ...Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external... ...safety issues for committees/expert groups; prepare publications and presentations... ...experience preparing and submitting IND and CTD submissions. Minimum/Preferred Skills Experience as...
- ...standards, document decisions, and coordinate across therapeutic areas to support regulatory submissions. Responsibilities include SDTM programming, defining datasets, and creating guides for FDA/PMDA submissions, while advancing training and communication across the #J-18...
- Atlantic Health is seeking a Radiology/Nuclear Medicine technologist to prepare and render radiopharmaceuticals for diagnostic and therapeutic studies at our Summit, NJ location. You will work under physician direction to calculate and administer doses, calibrate equipment...
- Atlantic Health System is seeking a registered nurse to collaborate with the healthcare team in treating patients with injuries, illnesses or disabilities. You will monitor patients, administer medications, educate patients, and help maintain comprehensive records. Responsibilities...
- ...The ideal candidate will have over 12 years of experience in the banking sector, focusing on the credit card issuer lifecycle and regulatory compliance. Responsibilities include collaborating with stakeholders, defining requirements, and ensuring successful delivery of...
- Atlantic Health in Summit, NJ is seeking a Registered Nurse to collaborate with a multidisciplinary team to treat patients with injuries, illnesses or disabilities. You will monitor patients, administer medications, educate patients, and maintain accurate records as part...
$103.6k - $192.4k
Job Description SummaryLocation: East Hanover, US #onsite Relocation Support: This role is based in East Hanover, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible.Role Purpose:Performs qualitative and quantitative analyses...Full timeRelocation package$138.6k - $257.4k
...Description SummaryTurn complex scientific data into insights that help advance the next generation of cell and gene therapies. As a Senior Expert Data Science within the Data and Statistical Sciences team, you will partner with development scientists, process engineers and...Full timeWork at office$108.5k - $201.5k
...department and cross-functionally Author and/or review method development reports, SOPs, validation reports and technical documents for regulatory filings Actively contribute to analytical development for clinical and commercial manufacturing and assist in advancing science-...Full timeRelocation package- Job ID: 20780356Reference Number: 23-01818Title: SAP Test ExpertLocation: Iselin, NJ, 08830Posted Date: 2023-11-02Company: HAN StaffingSAP Test Expert
$93.8k - $174.2k
...this role: please only apply if this location is accessible for you.Role Purpose:Bench to bedside! This exciting role serves as an Expert Science & Technology to develop, optimize, and implement novel analytical methodologies for our CAR-T cell therapy products. The successful...Full timeVisa sponsorshipRelocation package- Atlantic Health System in New Jersey is seeking a Registered Nurse to collaborate with a healthcare team in treating patients with a range of injuries, illnesses, and disabilities. You will monitor patients, administer medications, educate patients, and maintain comprehensive...
$166.72k - $250.08k
...Summary The Associate Director, Regulatory Affairs Advertising and... ...reviewer and subject matter expert for assigned scope and helps... ...approved in accordance with FDA regulations, guidance, approved... ...support required promotional submissions, including Form FDA 2253, Subpart...Work at office- ...Overview The Associate Manager, Regulatory Affairs supports the planning, preparation, submission, and maintenance of regulatory... ...Technical Documents format (eCTD) as required. Support the review... ...area): 6 Specific Knowledge: FDA regulations, and guidance;...Full timeWork at officeLocal areaMonday to FridayNight shift
$55 - $60 per hour
A leading technology service provider is seeking a Technical Business Analyst in Berkeley Heights, NJ. The role requires expertise in TDD, BDD, and Gherkin methodologies, alongside experience in business analysis for developing Java applications. This full-time position...Full time$100k - $120k
Position Overview Elite Providence Physical Therapy is seeking a dedicated and skilled Physical Therapist (PT) to join our team in Fords, New Jersey. This full-time position offers an opportunity to make a significant impact in the lives of our patients within a supportive...Relocation packageMonday to FridayFlexible hours- Atlantic Health in Summit, NJ, seeks a Radiologic Technologist to perform diagnostic, OR, and fluoroscopic radiology procedures with emphasis on patient positioning, technical factors, and image quality. You will support QA/QC for radiologic equipment, manage image production...Daily paid
$17.5 per hour
...our team members having meaningful experiences that help them build and develop skills for a career. The role of a Human Resources Expert can provide you with the skills and experience of:*** Understanding federal, state and local employment laws* Using basic Microsoft...Hourly payWork at officeLocal areaFlexible hoursShift workNight shiftDay shift
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