- Aequor (Newbury Park, CA)
- …and deliver training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents ... do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems /processes. Someone who...implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- The University of Vermont Health Network (Burlington, VT)
- …the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations ... standards is preferred.-Five years or more of increasing responsibility in systems , quality , or health care administration-Demonstrated management ability-Strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data ... Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited ... timelines. The Director will develop the process, tools and systems needed to build a core dossier for global...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …certifications:Preferred Educational Requirements: Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research.Other: Job ... expedited, full-board review).Actively participates in the development, implementation, monitoring, and regulatory oversight of high quality research within the… more
- DivIHN Integration Inc (Santa Clara, CA)
- …experience and/or 2 years relevant industrial experience typically with a quality , product-development/support, or scientific affairs function. Seeking candidate ... one of our Talent Specialists Rashi at ### Divya at ### Title: Regulatory Specialist II Location: Santa Clara, CA Duration: 6 Months Description: Exempt/Non Exempt:… more
- Catalent (San Diego, CA)
- …or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... products and dosage forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan and overseeing the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of relevant and current work experience in pharmaceutical / biotech / CDMO industry Quality Assurance and Regulatory Affairs required10+ years of progressive ... and product complaint investigations and GxP archivesDirect development and implementation of quality systems to ensure product reliability, quality ,… more
- Tris Pharma (Monmouth Junction, NJ)
- …planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality , etc. to ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS)… more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and… more
- Beacon Hill Staffing Group, LLC (Raleigh, NC)
- …for grammar and vocabulary, and acting as the back-up receptionist for the Regulatory Affairs Division. Provides support to staff and Commission members on ... Work is performed under the supervision of the Director and Assistant Director of Regulatory Affairs as well as the Compliance Manager, and is evaluated through… more
- TalentBurst, Inc. (Cambridge, MA)
- …be as short as 3 months-up-to 6 months.Job Summary: The US Commercial Regulatory Affairs Promotional Review Committee (PRC) Coordinator is responsible for ... during their life cycle 2) interfacing with brand/Originator and regulatory to assist with system execution of Regulatory...and have you worked with any other electronic review systems ?2. Were you a Coordinator for a Medical Review… more
- Abbott (Santa Clara, CA)
- …5-7+ years of experience in clinical research, clinical affairs , regulatory affairs , or quality systems , in the medical device or pharmaceuticals ... device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking… more
- Tecomet (Kenosha, WI)
- …provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems , encompassing both improvements and sustaining ... **Sr. Quality and Regulatory Affairs ...customer quality requirements, create, monitor and improve quality systems /programs, reduce quality costs… more
- Boehringer Ingelheim (St. Joseph, MO)
- …reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director, Regulatory Affairs Pharma Safety & Efficacy you will: Act as ... Regulatory Affairs (RA) team member in projects...Regulatory Affairs (RA) team member in projects as well as...quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.… more
- ACLD (Bethpage, NY)
- …service delivery systems . Assist in the development and implementation of Regulatory Affairs related staff training activities in Residential and Day ... Regulatory Affairs Analyst Help Others to...policy. + Assist in the development of internal compliance systems and controls. + Assist in completing quarterly and… more
- Teleflex (Wyomissing, PA)
- Regulatory Affairs Specialist **Date:** Apr 19, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** :9538 ... make a difference in patients' lives. **Position Summary** This is a mid-level regulatory affairs position that requires the ability to integrate regulatory… more
