- Vera Therapeutics (Brisbane, CA)
- … regulatory and clinical document production. * Support clinical and regulatory document preparation (eg, eCTD modules, briefing documents, study ... clear, accurate, and effective presentation of analyses and messaging. * Manage document timelines, ensuring alignment with overall regulatory and program… more
- JPMorgan Chase (New York, NY)
- …automation solutions **Preferred qualifications, capabilities, and skills:** + Experience in regulatory document preparation and governance a plus ... function is responsible for the first-line critical review of internal and regulatory governance materials in keeping with the OCC's Heightened Standards for… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …Description:** **JOB SUMMARY:** Responsible for regulatory assessments, coordination and preparation of document packages for regulatory submissions ... of changes on existing products. + Coordinate and prepare document packages for regulatory submissions to the...+ 3 -5 years of experience in Medical devices regulatory submissions required. + Experience with successful preparation… more
- Santa Clara Valley Water District (CA)
- …of California Environmental Quality Act (CEQA) and/or National Environmental Policy Act (NEPA) document preparation or regulatory compliance? If so, consider ... or capital projects or facilities on the community and the environment. + Preparation of CEQA/NEPA documents and/or successful regulatory permit negotiation and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various ... guidelines, ICH guidance, and Teva standards + Lead/contribute to the preparation /revision of document templates + Participate in the recruiting/hiring process,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …authorization, etc.) for US regulatory submissions. + Support FDA meeting preparation including preparation of briefing document , meeting request, ... response to FDA preliminary comments and logistics. + Support FDA meeting preparation including preparation of briefing document , meeting request, response… more
- Stanford Health Care (Newark, CA)
- …medical records .The Document Imaging (DI) Specialist is responsible for document preparation , scanning, and indexing paper documents to accurately file in ... of America) **This is a Stanford Health Care job.** **A Brief Overview** The Document Imaging Specialist, under the leadership of the HIM Document Imaging… more
- Sanofi Group (Bridgewater, NJ)
- …and/or innovative biologics products + Demonstrated experience with driving the preparation of regulatory documents (eg (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health ... **Job title: Regulatory Strategist** + **Location:** Cambridge, MA or Bridgewater,...their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading… more
- System One (Florham Park, NJ)
- …The Senior Regulatory Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, ... The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version...systems to this role. Responsibilities + Lead in the preparation and submittal of regulatory applications and… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Exelon (Washington, DC)
- …the analysis to appropriate management. 3. Apply critical analytical skills in the preparation of regulatory data filing requirements for rate case (distribution ... and respond to Commitments tracking inquires and maintenance. Enforce document control policies and deliver training in records and...management (25%) + Provide data and support for the preparation of written testimony, regulatory audits and… more
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as Veeva Systems products, ... health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research Regulatory … more
- Actalent (Cambridge, MA)
- …ensuring accuracy and compliance, supporting training management, and assisting with regulatory inspection preparation . This hybrid role includes both remote ... Job Title: Document Control Specialist Position Summary: We are seeking...tasks, creating quizzes, and formatting SOPs. + Assist in regulatory inspection preparation and provide onsite support… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Regulatory Strategist **Location** : Cambridge, MA **At this time, Sanofi will not sponsor a new applicant for employment authorization, or offer any ... progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...+ Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial… more
- IQVIA (Ithaca, NY)
- …matrices, tissue preparation , or purification as required. + Conduct and document testing in accordance with SOPs and applicable regulatory guidelines. + ... We are seeking a **Associate Scientist, Sample Preparation ** to join IQVIA Laboratories at **Ithaca, NY**...calculations, and collect data for evaluation. + Identify and document potential performance errors or unusual results, escalating issues… more
- Sumitomo Pharma (Columbus, OH)
- …of effectively negotiating with others while maintaining composure + Development and preparation of successful regulatory strategies and the ability to ... contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary + Prior history with… more
- Sumitomo Pharma (Columbus, OH)
- …line with the global registration strategy in collaboration with the global regulatory leader (GRL) + Leads preparation , coordination, authoring and monitoring ... the ability to contribute to the development and writing of a regulatory strategy document in coordination with clinical plans and marketing objectives + Proven… more
- Actalent (Gaithersburg, MD)
- …requirements. This role involves providing strategic and operational oversight, supporting the preparation and execution of regulatory plans. The Director will ... Title: Director, Regulatory Affairs Operations Location: 100% REMOTE (must be...regulatory submission publishing standards and procedures, including electronic document management systems. + Technical Skills : Proficient in… more
- Vera Therapeutics (Brisbane, CA)
- … regulatory requirements for different application types. Responsibilities: * Assist the Regulatory Operations Lead in the preparation of regulatory ... Title: Senior Manager, Regulatory Operations and Publishing Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company… more
- Sanofi Group (Swiftwater, PA)
- **Job title: Regulatory Strategist** + Location: Bridgewater, NJ or Swiftwater, PA or Waltham, MA (ability to work onsite 2-3 days each week per hybrid working ... adults. Our team is responsible to develop and execute regulatory strategy for this new asset to protect toddlers...launch. + Lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial… more