- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all content, community interactions, and account activities comply with legal, regulatory , and corporate standards.- Collaborate with legal, compliance, and other ... social media channel registry portal- Identify complaint model for global user access/ publishing including but not limited to Business Manger based assess and/or… more
- Sumitomo Pharma (Lincoln, NE)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing , distribution, and archiving… more
- System One (Florham Park, NJ)
- …to ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control, ... Qualifications + Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. Prior… more
- J&J Family of Companies (Spring House, PA)
- …within and across TAs independently. + Contributes to and champions internal standards, regulatory , and publishing guidelines. + Contributes to and champions the ... are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to...+ Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in… more
- Teva Pharmaceuticals (West Chester, PA)
- …and program level Preferred: + 2 Years of experience related to clinical document publishing or regulatory submission publishing + 2 Years of experience ... to make a difference with. **The opportunity** A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other… more
- Takeda Pharmaceuticals (Boston, MA)
- …to evaluate the impact of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing , CMC, drug labeling, compliance, and IT) ... opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director, Regulatory Data Governance Lead **POSITION DESCRIPTION** : Takeda Development Center… more
- Vera Therapeutics (Brisbane, CA)
- …for briefing documents and agency meetings. * Coordinate submission scheduling with regulatory publishing and ensure delivery of high-quality documents. * May ... our lead late-stage development Program, Atacicept, in alignment with Vera's Regulatory strategy and our commitment to health authorities globally. Responsibilities:… more
- AbbVie (Irvine, CA)
- …role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Leads the ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (South San Francisco, CA)
- …Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities + Leads ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (Jersey City, NJ)
- …The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. + Leads the statistical ... sets for individual studies and integrated data. + Create documentation for regulatory filings including reviewers guides and data definition documents + Leads the… more
- J&J Family of Companies (Spring House, PA)
- …tasks per established procedures. + Gains knowledge and applies internal standards, regulatory , and publishing guidelines. + With increasing skill, uses internal ... + Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Development Technologies (CTMS, EDC, eTMF, IRT, eCOA, DCT solutions). Regulatory Affairs Technologies (RIM systems, publishing tools, global submission ... **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The regulatory operations specialist position provides support across multiple functional areas, including ... regulatory intelligence, device establishment registration and listing (FURLS), global...registration and listing (FURLS), global unique device identification (UDI), publishing , and translations. The role also involves proficient use… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management ... associated software, and accessories on a global scale. **Responsibilities** + Support regulatory efforts to comply with new and existing US and international… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties: +… more
- ERCOT (Austin, TX)
- …rules, and reliability-related provisions of the Public Utility Regulatory Act; Providing reliability-related subject-matter advice, expertise, and assistance ... reliability-related items + Contributes to the writing, editing, and publishing of reports and filings required by the PUC...research and drafting legal documents + Representing ERCOT in regulatory matters + Keeping abreast of legislative or … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Primary** **Responsibilities:** + Support regulatory effort to comply with new and existing regulations (eg, FDA Medical ... Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive continuous improvement in… more
- MyFlorida (Tallahassee, FL)
- REGULATORY SPECIALIST II (Agenda Processor) - 64085501 Date: Jul 23, 2025 The State Personnel System is an E-Verify employer. For more information click on our ... . Requisition No: 857300 Agency: Department of Health Working Title: REGULATORY SPECIALIST II (Agenda Processor) - 64085501 Pay Plan: Career Service… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle ... and actively resolve technical issues. + Responsible for both report level publishing and submission level compilation for global major applications and lifecycle… more
- Navient (San Francisco, CA)
- …Content Operations Specialist, you will:** + Lead end-to-end content publishing workflows, managing blog and webpage updates, coordinating cross-functional teams, ... and tracking key performance metrics like publishing velocity and content freshness. + Oversee legal and compliance processes, serving as the primary point of… more
