- Merck & Co. (Rahway, NJ)
- …Staff , Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ 4 more}-Preferred Skills:Job ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global … more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry. Education area of… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part of the ... US Medical Affairs team, the Senior Medical Science Liaison (MSL) will...local point of contact for investigators and their research staff who may participate in company sponsored and investigator… more
- Beckman Coulter Diagnostics (Miami, FL)
- …continuity risks.Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality, and Regulatory Affairs to embed quality into all phases of ... to internal quality standards, customer requirements, and applicable external regulatory frameworks. Provide structured feedback and corrective action follow-up to… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- BEL (Little Chute, WI)
- …support departmental objectives. Work in conjunction with the Analyst, Quality Assurance and Regulatory Affairs and/or Manager, Quality and Regulatory ... Inspirationally lead and develop the lab team. Conducts regular staff meetings and team building. Demonstrate a passion for...Quartz module. Provide back-up to Analyst, Quality Assurance and Regulatory Affairs and Sr. Manager, Quality and… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... mentoring junior staff . Maintaining laboratory equipment, ensuring safety and regulatory compliance, and supporting audits are also part of the… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...and first-line managers and statistical staff focused on end to end statistical activities that… more
- Veterans Health Administration (North Bend, OR)
- …to direct the specimens to the proper location. S/he notifies the laboratory staff of the need for emergency testing. Demonstrated ability to cope with stressful ... of need for send-out testing, packages and ships containers following regulatory guidelines, maintains shipping certification, assists the laboratory in functions… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... etc.Assist with employee relations issues, as needed, which may include coaching staff members and management on policies, as well as providing documentation.Assist… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** Staff Regulatory Affairs Specialist - Franklin Lakes NJ BD Specimen Management (SM) offers a comprehensive range of solutions ... and specimen management products, to sample analysis and accurate reporting. The Staff Regulatory Affairs Specialist is responsible for preparation of US and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in ... Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs perspective. + Support efforts for Technical File creation, remediation,… more
- Kelly Services (Valencia, CA)
- …documentation. + Support quality training and system improvements. + Supervise and develop Regulatory Affairs staff . + Travel between Valencia, Burbank, and ... + ** Regulatory Affairs Manager** + **Location:** Onsite in Valencia & Burbank, CA + **Salary:** $100,000-$140,000/year (DOE) + **Industry:** Medical Device /… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Specialist Regulatory Affairs , you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with ... Life Sciences, or a related field. + 3-5 years of practical experience regulatory affairs , with a focus on SaMD. + Comprehensive understanding of FDA regulations… more
- ACLD (Bethpage, NY)
- …quality of service delivery systems. Assist in the development and implementation of Regulatory Affairs related staff training activities in Adult Service ... Regulatory Affairs Analyst When a group... Regulatory Affairs Analyst When a group of families came...Today, we are a leading not-for-profit agency employing 1200+ staff and providing over 70 program sites in Nassau… more
- Bristol Myers Squibb (Indianapolis, IN)
- …teams, remote and SD teams, participate in and/or lead multifunctional teams + Manage Regulatory Affairs - CMC staff + Assess manufacturing Change Controls ... We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)** . This...cares about your well-being and the well-being of our staff , customers, patients, and communities. As a result, the… more
- Takeda Pharmaceuticals (Boston, MA)
- …and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory ... experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations… more
- Williams Companies (Washington, DC)
- …learn and grow with us. Day in the Life: As a State Government & Regulatory Affairs Rep Sr/ Staff supporting the Mid-Atlantic and Northeast region, you'll ... bring your energy to ours! The State Government & Regulatory Affairs Rep Sr. is responsible for...a minimum of eight (8) years of experience as staff in a State House, Governor's office, or federal… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs /Compliance experience in medical devices + Experience with end-to-end SaMD ... (including all documents required under risk files). + Knowledge of global Regulatory Affairs requirements, regulations, and standards + Strong prioritizing,… more
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