- Cepheid (Miami, FL)
- …for functioning as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous ... the opportunity to:Function as Lead Auditor to schedule, plan, perform, and document internal audits to provide continuous and rigorous assessment of the Cepheid… more
- Savannah River Mission Completion (Aiken, SC)
- **Overview** Savannah River Mission Completion (SRMC) is seeking a ** Regulatory Document Developer** to be based in our Aiken, SC location on the Savannah River ... support for tank closure and salt waste disposal activities and projects. The ** Regulatory Document Developer** will interface with regulatory stakeholders,… more
- Amgen (Washington, DC)
- … Information Management System (eg VeevaVault) and support the department in regulatory document management activities. + Maintain regulatory SharePoint ... these credentials. **Basic Qualifications:** **Must have in depth knowledge of regulatory document management systems including content management and archival,… more
- Takeda Pharmaceuticals (Boston, MA)
- …including regulatory submissions, labeling, and product tracking; Oversee Regulatory Document data classification rules, compliance/retention rules, and ... data tagging and management, metadata standards and data discoverability; Maintain the Regulatory Data Catalog: Document Data classification and quality rules;… more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site… more
- Takeda Pharmaceuticals (Boston, MA)
- …book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory ... to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU...and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the… more
- University of Miami (Miami, FL)
- …include, but not be limited to: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...CORE JOB SUMMARY: The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting… more
- Actalent (Parsippany Troy Hills, NJ)
- …Good Documentation Practices (GDP) compliance, ensuring adherence to formatting standards and regulatory requirements. Document Systems & Compliance + Manage the ... + In-depth knowledge of GxP-compliant document control practices, including document lifecycle management and regulatory documentation. + Proven experience… more
- University of Miami (Miami, FL)
- …provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, ... review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Remote SCCC Regulatory Analyst II reviews, prepares, and provides oversight for… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Takeda Pharmaceuticals (Boston, MA)
- …CTN, IND, CTA, PSP, PIP, 15-day safety notifications, and rapid response document ; Submission planning and management of Regulatory submissions: Collaborate with ... Regulatory EDMS and business development support: Provide end-user support for Regulatory electronic document management system (EDMS); Create job aids to… more
- Lilly (Indianapolis, IN)
- …could impact the global product strategy or brand. + Enable discussion of the regulatory strategy document and regulatory issues/challenges at the ... the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Sanofi Group (Cambridge, MA)
- …meet current and future data needs including the investigation and analysis of complex regulatory data / document issues. Based on the investigation and analysis ... **Job Title:** Lead, Regulatory Data **Location** : Cambridge, MA, Morristown, NJ...quality excellence and digital expertise with pharmaceutical and biotechnology regulatory knowledge to drive strategic projects. This position will… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools. ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of product clearances and maintain the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools ... self. Become a **maker of possible** with us. **Overview** As Staff Specialist, Regulatory Affairs, you will develop and implement medical device regulatory … more
- Terumo Neuro (Aliso Viejo, CA)
- …devices are commercially available in the assigned market(s) based on the approved regulatory strategy. + Document , consolidate, and maintain verbal and written ... **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking and to ensure ... . **Job Description** The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy… more
- System One (Pittsburgh, PA)
- …(SOPs), batch records, and other forms according to company standards and regulatory requirements. + Electronic Document Management System (EDMS): Manage the ... Job Title: QA Document Specialist Location: Onsite/Pittsburgh, PA 15219 Type: Direct-Hire Start date: End of May Overview: Join an innovative biotech team at the… more
- Kelly Services (Nashville, TN)
- … document control, training, and providing comprehensive quality and regulatory support for both operations and pharma services. **Job Responsibilities:** + ... + Perform other tasks as assigned. **Lead Activities for Regulatory Processes:** + MLR Document Approval + External Standards + Assist with submission projects… more
- Actalent (St. Louis, MO)
- …dossiers, safety data sheets, and compliance reports. + Maintain and update regulatory databases and document management systems (eg, SAP). + Coordinate ... Regulatory Administrative Assistant Job Description The Regulatory Administrative Assistant will provide critical support to the Regulatory Affairs team,… more
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