- Insmed Incorporated (NJ)
- …the Associate Director, you will ensure high-quality, timely, and compliant preparation and delivery of regulatory documentation throughout product lifecycles. ... regulatory requirements, and internal quality standards Author and oversee the preparation of regulatory documents and meeting materials (eg, meeting… more
- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM ... Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible...controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11,… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …working in the pharmaceutical and/or healthcare industry. Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug… 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 - Oncology TAU...support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support… more
- CSL Behring (King Of Prussia, PA)
- …regulatory activities as assigned, inclusive of potential to contribute to core document preparation (eg, core briefing book, pediatric plans, etc.), product ... filing preparation activities (investigational, new, and marketed) and health authority...+ Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence. Ensures… more
- Lilly (Durham, NC)
- …This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR ( ... Regulatory Compliance and Post Market Reporting) team. This includes...as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions,… more
- GE HealthCare (Chicago, IL)
- …Job Description Roles and Responsibilities Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation , ... and ensuring strategy is executed to current industry practices and regulatory expectations. Standardization of processes, tools, and performance management system.… more
- TreeHouse Foods, Inc. (Manawa, WI)
- …management. . Participate in GFSI, regulatory , and customer audits, including document preparation , on-site assistance, and follow-ups for food safety and ... attempt to impersonate our company by sending fake job offers, interview, and sensitive document requests. If you receive an email claiming to be from us, always… more
- AbbVie (North Chicago, IL)
- …Chicago, Irvine, South San Francisco, Worcester MA, Waltham, MA Leads global regulatory dossier preparation activities for novel biologics by coordinating ... internal and external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and… more
- Eisai, Inc (Bethesda, OH)
- …is responsible for leading, managing, strategizing, and overseeing the planning, preparation , coordination, and delivery of global regulatory submissions in ... regulatory requirements, and data standards (eg, CDISC).Extensive experience with Regulatory Information Management (RIM) systems and Document Management… more
- PCI Pharma Services (Philadelphia, PA)
- …Operations, this role ensures that PCI's employment practices, including regulatory adherence, work authorization, policy management, government reporting, and ... compliance programs, and the ability to operationalize HR policies and regulatory requirements across various systems, processes, and teams. Responsibilities: Global… more
- Cipla (Fall River, MA)
- …revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role the Validation Engineer adheres to the ... company's document and SOP's procedures while ensuring their accuracy, quality,...equipment and products in compliance with site SOPs and regulatory guidance. Autonomously leads and manages projects to implement… more
- Insmed Incorporated (NJ)
- …using the Veeva Quality Management System to ensure alignment with regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory ... a key audit contact point by assisting with documentation and report preparation .Own and improve the deviation lifecycle management process within Veeva, ensuring… more
- Stony Brook University (Stony Brook, NY)
- …or calculations; mail, supply, and inventory functions; keyboarding and other document preparation tasks; answering telephones; completing forms; assisting ... of value such as cash or vouchers. Keyboarding and Document Preparation Type, proofread, review, and correct...references. Successfully complete a 4 panel drug screen Meet Regulatory Requirements for pre employment screenings. Provide a copy… more
- Stony Brook University (Stony Brook, NY)
- …or calculations; mail, supply, and inventory functions; keyboarding and other document preparation tasks; answering telephones; completing forms; assisting ... title. **Preferred Qualifications** Experience with Cerner Power Chart - Document preparation , Document QC, CPDI...complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + Provide a… more
- Twist BioScience (South San Francisco, CA)
- …sequencing. Direct experience with automation platforms for high-throughput library preparation .Familiarity with regulatory requirements or quality control ... execute rigorous experimental plans to test and optimize various NGS library preparation kits and sequencing platforms (eg, Illumina, PacBio, Oxford Nanopore) with… more
- Cipla (Fall River, MA)
- …maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA, ). Maintain and ensure the proper documentation of all ... quality systems and records. Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work instructions, and other quality documents… more
- Williams Companies (Wysox, PA)
- …with preparation of environmental reports, plans and inventories for regulatory authorities + Responds to requests from internal and/or external customers + ... remain within legal limits. Your day includes gathering operational data, submitting regulatory reports, and handling permit renewals under tight deadlines. You will… more
- Hawaiian Electric (Honolulu, HI)
- …Maintains internal control records, supports audit readiness activities, manages document workflows, and supports continuous improvement of WS processes. Ensures ... as designed, and in adherence to plans and standards and aligned with regulatory expectations. + Develops data and reporting tools that support the development of… more
- Teleflex (Wyomissing, PA)
- …with minimal supervision. The Scientist contributes to project deliverables, supports regulatory and design control activities, and provides technical expertise to ... medical device evaluation, ensuring compliance with protocols, quality systems, and regulatory requirements. - Prepare, optimize, and perform biological assays and… more
