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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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Own conference and event calendar; lead planning and execution for BioPharma including collaborating with marketing, bioinformatics and scientific affairs to develop the correct content; support event logistics where necessary; assess competitive landscape to inform and optimize our conference / event calendar.
$104,400 - $187,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge of state & federal OSHA, US Coast Guard regulations, PSMSC and other safety regulatory requirements for the maritime industry. The Per Diem Operations Manager issues discipline and grievances through the Foreman as necessary.
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
$90,000 - $137,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Thorough understanding and working experience of pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
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Collaborate with cross functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK and tox, as well as program management) to ensure CMC and program goals are met.
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You will collaborate with Medical Affairs Technology and Medical Excellence personnel, Legal and Regulatory personnel and Medical Affairs colleagues to evolve our content oversight, management and CRM platforms to enable an efficient review and approval of materials, ensure the proper storage and fulfillment of materials, and track how of our medical content is used externally.
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Knowledge of regulatory requirements for air quality, water quality, EMS, zero waste, cultural, ecological aspects, tiered permitting, NEPA, and spill reporting/SPCC, is strongly preferred. SLAC National Accelerator Laboratory, Environmental, Safety & Health (ESH) Division’s Environmental Protection Department is seeking an Environmental Engineer to be a program manager/subject matter expert within SLAC’s Environmental Compliance Group.
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Collaborates with Customer Success Manager and operational partners to triage KYC, Sanction and High-Risk Industry and Fraud alerts. The Customer Success Manager manages a portfolio of borrowing and non-borrowing clients and is responsible for delivering an overall delightful client experience which includes client onboarding, client servicing and proactive client solutioning.
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Job Description: IMMEDIATELY HIRING Event EMS Supervisor PART-TIME Opportunity Location: San Francisco, CA We're hiring Event EMS Supervisors to work with the Manager of Operations to ensure that all Field Supervisors, Support Services Department, Field Personnel, vehicles, and equipment operate in an efficient and effective manner.
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Rudolph & Sletten, a Tutor Perini Company, is seeking a Senior Project Manager to join our office in Menlo Park, CA About Rudolph & Sletten:In the last six decades, Rudolph and Sletten has built thousands of projects across our five California offices, from research centers designed to cure diseases, to institutions that educate future generations, to civic facilities and high-tech campuses that move our state forward.
$180,000 - $215,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Act as a liaison between field personnel, Manager of Operations, and the General Manager. Coordinate with the field training officers and clinical manager to identify clinical opportunities for improvement and provide follow-up as necessary.
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regulatory affairs manager jobs Title: north america in Foster City, CA
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