- Parexel (Montpelier, VT)
- …investigators. + In some countries, as required, CRAs are accountable for study start - up and regulatory maintenance. Tasks may include Site Qualification ... the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start - up and for the duration of the study. +… more
- Parexel (Columbia, SC)
- …investigators. + In some countries, as required, SrCRAs are accountable for study start - up and regulatory maintenance. Tasks may include Site Qualification ... the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start - up and for the duration of the study. +… more
- Parexel (Hartford, CT)
- …responsible with CRA for enrollment delivery during study conduct + Partners with local Regulatory authorities and Study Start up teams to ensure timely ... for investigative sites throughout a study's lifecycle, responsible for site start - up , activation, relationship management, recruitment, and quality assurance.… more
- Delek US Holdings (Dallas, TX)
- Sr Regulatory DOT Compliance Specialist - Open to Field Location Location: Dallas, TX, US, 75024 Are you looking for a career in a dynamic and innovative company ... terminals. **DELEK BENEFITS:** We offer fantastic benefits that include up to a 10% match on 401K on your...to a 10% match on 401K on your hire start , with a vesting timeline of only one year,… more
- Huntington Ingalls Industries (Newport News, VA)
- MGR REGULATORY COMPLIANCE 3 Location: Newport News, Virginia, United States Date: Dec 12, 2025 Req ID: 44377 Team: O55 SCM CMPL/OPS/CMCL PRC Entity: Newport News ... No - Not eligible for telework Travel Requirement: Yes, up to 10% of the time Clearance Required: No...time Clearance Required: No - Clearance Not Required to Start **Meet HII's Newport News Shipbuilding** With more than… more
- BeOne Medicines (Emeryville, CA)
- …submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and ... timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region...local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used… more
- Syner-G BioPharma Group (Boston, MA)
- …or systems for compliance with manufacturing requirements and facility fit.Lead start - up activities, including commissioning and qualification of facilities, ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- ValSource, Inc. (Rahway, NJ)
- …in the manufacturing field. Also responsible for activities related to the start - up , commissioning, qualification, validation of Pharmaceutical and Biotech GMP ... requirements to include but not be limited to: project installation and start - up activities, client meetings, company sponsored meetings, trainings. Proficiency… more
- Formation Bio (New York, NY)
- …GXP and CSV experienced team members. Track record of success in a biotech start - up or fast-paced, innovative, dynamic environment, with the ability to remain ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Stony Brook University (Stony Brook, NY)
- …and timely reporting of patient results and compliance with all regulatory standards. Qualified candidates will demonstrate superior patient care and possess ... + Oversight of QA functions and monitors. Ensures staff compliance with all regulatory agency standards. Takes corrective action as needed. Insures the validity of… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Endo International (St. Louis, MO)
- …that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director ... findings and conclusions; work with Research and Development during new product start -ups, and establish key checkpoints for new products and processes Centers of… more
- BWX Technologies, Inc. (Oak Ridge, TN)
- …for building and overseeing the organization's EHS programs from the ground up , ensuring operational readiness, regulatory success, and a deeply embedded ... Licensing & Safety to lead the development and execution of world-class regulatory compliance, safety, licensing, and quality programs for our advanced uranium… more
- Olympus Corporation of the Americas (Westborough, MA)
- …support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject ... for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304,...?exibility in work hours will be expected. + Travel up to 15% of the time. Candidate will be… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …for clinical data acquisition, quality checking and reporting. + Focus on study- start up and database amendment implementation. + Study level coordination ... and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices...role manages trials in various stages, from planning, to start - up , conduct, closeout, and archiving. The role… more
- Cipla (Fall River, MA)
- …materials to purchase by aligning with the production plan and regularly following up for delivery monitor inventory levels and coordinate with planning & sourcing ... as per the requirement by coordinating with production and follow- up with purchase for timely delivery Provide status of...compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Pfizer (Groton, CT)
- …to support clinical development implementation and contribution to key development milestones, eg start - up and delivery of ESoE and PoC trials. Participate in ... project teams to help implement clinical development and contribute to key milestones (eg, start - up and delivery of early signs of efficacy ESoE and POC trials).… more
- ICL (St. Louis, MO)
- …customer interactions in the CRM system with written call reports. + Maintain up -to-date pricing in CRM. + Collect market analysis information in CRM. + Provide ... including product bulletins, application data sheets, and promotional materials. ** Regulatory & Compliance** + Assist the corporate regulatory...same. + Ability to travel overnight within the USA up to 30% of the time **Compensation at ICL:**… more
