Sr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
Regulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
NewAssociate Director, Global Medical & Promotional Regulatory Affairs Jazz PharmaceuticalsAssociate Director, Global Medical & Promotional Regulatory AffairsRemote$160,000–$240,000 / yearThe Associate Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group and will be leading the promotional materials review activities; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewRegulatory Specialist # 26-22388 US Tech Solutions, Inc.Regulatory Specialist # 26-22388Reynoldsburg, OHResponsibilities Individual contributor Responsible for providing day to day global regulatory support & execution for the Regulatory Affairs department to aid in the successful launch and lifecycle of compliant products from ingredient review to label assessment to government product submissions, documentation, and related dossiers to ensure accuracy and completeness for global product launches. US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.Director, Global Regulatory Affairs (GRL)Basking Ridge, NJ$193,040–$289,560 / yearFull timeThe GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.
Associate Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Associate Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
NewDirector, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
NewRegulatory Affairs Manager CYNET SYSTEMSRegulatory Affairs ManagerIndianapolis, IN$48–$53 / hourTemporaryContractorPart timeAs a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. 3-5 years of experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs, Medical devices, Pharma, or Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
NewRecords & Information Specialist ECLARORecords & Information SpecialistWhite Plains, NYPosition Overview: The Records & Information Specialist role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Familiarity working with a Records Retention Schedule by associating documents with their Record Series Titles, retention periods, regulations, and RM File Numbers.
Regulatory Affairs Specialist Regulatory Affairs Specialist LancesoftRegulatory Affairs Specialist Regulatory Affairs SpecialistTrumbull, CT$30Skills —strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Manage workload, priority and performance of regulatory staff, in addition to providing development opportunities to build capability.
NewSenior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist CSLSenior Manager GRA CMC Combination Product and Stand Alone Medical Device SpecialistKing of Prussia, PAIn-depth knowledge of global device regulatory requirements, including but not limited to: EU MDR, ISO 13485, ISO 14971, ISO 15223, ISO 10993, IEC 62366, IEC 62304, IEC 60601, ISO 20916, ISO 18113, ISO 23640, 21 CFR Part 820, IEC 62304:2006, ISO 14971:2019, QSR, and BIMO compliance. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
NewFamily Nurse Practitioner - Up to $4,000 Relocation Assistance Fast Pace HealthFamily Nurse Practitioner - Up to $4,000 Relocation AssistanceMillwood, KYPosting Title: Family Nurse Practitioner - Up to $4,000 Relocation Assistance Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
NewGRA CMC Specialist CSLGRA CMC SpecialistKing of Prussia, PASupport the collaboration with CSL’s Corporate & External Affairs organization to support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
Revenue Cycle Operational Improvement Specialist St. Luke's Health Network, Inc.Revenue Cycle Operational Improvement SpecialistAllentown, PAFull timeContent includes but is not limited to the following: registration, insurance, online eligibility, address verification, financial clearance, financial counseling, price estimates, price transparency, business office procedures, work queue’s, customer service, scheduling, referral/authorizations, etc. Schedules and performs Revenue Cycle Workshop for hospital and SLPG new hire and existing employees to explain the impact various departments have on the revenue cycle and gain a stronger understanding of their individual roles within the revenue cycle.
NewFamily Nurse Practitioner/Physician Assistant - Up to $5K Sign On Bonus Fast Pace HealthFamily Nurse Practitioner/Physician Assistant - Up to $5K Sign On BonusCoal City, INPosting Title: Family Nurse Practitioner/Physician Assistant - Up to $5K Sign On Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Family Nurse Practitioner / Physician Assistant Fast Pace HealthFamily Nurse Practitioner / Physician AssistantMidway, TNPosting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Staff Regulatory Affairs Specialist, Advertising & Promotion Becton Dickinson Medical DevicesStaff Regulatory Affairs Specialist, Advertising & PromotionOur Staff Regulatory Affairs Specialist position is primarily focused on compliant advertising and promotion of our existing Specimen Acquisition and Lab Specimen Management product portfolios, in addition to opportunities to provide regulatory support for new product claims. This role ensures claims and communications are truthful, non-misleading, appropriately substantiated, aligned to approved indications/intended use, and compliant with applicable US, EU, and global medical device/IVD requirements.
Regulatory Affairs Specialist (Innovation) Becton Dickinson Medical DevicesRegulatory Affairs Specialist (Innovation)Sparks, NevadaRemote$95,900–$153,400 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products.
Regulatory Affairs Specialist (CMC) Zp Group LlcRegulatory Affairs Specialist (CMC)Durham, NC$60,000–$85,000 / yearThe Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.
Regulatory Affairs Specialist II - Labeling & Promotion Avion PharmaceuticalsRegulatory Affairs Specialist II - Labeling & PromotionAlpharetta, GeorgiaThe Regulatory Affairs Specialist II is responsible for independently preparing submissions in eCTD format, label and promotions participant for Regulatory Affairs in client meetings, interact with the various governmental agencies when needed, and assess promotional and labeling changes for regulatory impact. Independently prepare complete submissions in eCTD format according to supplied checklist(s) – Label supplements, OPDP materials, Annual Reports, and other product correspondence as needed.