Associate Director, Translations Regulatory Submissions Project Management
hace 3 semanas
The Associate Director Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations.This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL and any other regulatory materials for EMA, SwissMedic, FDA and rest of the world.Lead Regulatory submission Team Leaders under his / her remit and ensure the whole team meets and exceed their monthly and yearly goals and objectivesLead and implement processes to improve efficiency and to ensure high quality deliverables for all Regulatory Submissions projectsCoordinate with colleagues in other departments to develop and expand on existing workflows and offeringsRepresent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projectsAct as main point of contact for internal / external clients and manage any escalations or issues that may arise within the teamLiaise with the client to establish methodologies and to assess and agree project parameters and requirementsPrepare and implement smooth on-boarding plans for future new clientsCoordinate and communicate with interviewers and recruiters for the purpose of conducting debriefing interviews, analysing results, and making recommendations for improvements.Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter expertsMonitor and manage the status of the teams’ projects to effectively anticipate and prevent issuesEnsure that the team accurately and timely complete project finances including quoting and budgetingUnderstand and adhere to the Quality Management SystemComply with relevant and applicable IQVIA procedures and SOPsMaintain and update SOPs when applicableWork with Team Leads to help in the training and development of junior staffClosely collaborates to Quality and Compliance team to ensure best standards are reach.Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plansContribute to develop a continues improvement culture where productivity and quality standards ) should be raised year by year through the usage of state of the art technologies and IQVIA Lean Best PracticesGet trained as IQVIA Lean Manager to be able to effectively lead / Collaborate in IQVIA Lean initiativesWhen assigned, ensures the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge)Requirements :Minimum of 5 years of experience specializing in Regulatory Submissions as a Manager, Team Leader, Director or Associated Director in the Life sciences Language Services industryExperience in leading a team of Project Managers within Regulatory SubmissionsBachelor’s degree, ideally in a linguistic, business or scientific fieldFluency in English is essential, an additional language would be advantageousExperience in Russian Regulatory submissions will be highly consideredExcellent written / verbal communication skillsExcellent attention to detail to ensure that high quality standards are maintainedAbility to meet strict deadlines and to manage competing priorities and changing demands.Excellent problem solving and analytical skillsAbility to follow instructions and work independently whilst using own initiative.Demonstration of advanced IT skillsExperience working with technical files, TMS and CAT tools, experience working with XTRF and / or MemoQ would be highly advantageousAbility to establish and maintain effective working relationships with colleagues, managers and clientsIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at
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España Iqvia A tiempo completoAssociate Director – Regulatory SubmissionsThe Associate Director – Regulatory Submissions is responsible for leading a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director – Regulatory Submissions has...
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Associate Director, Regulatory Affairs
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España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
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España ICON plc A tiempo completoStudy Start Up Associate II - Spain, Madrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Study Start Up Associate / Regulatory Submissions -...
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España Sandoz A tiempo completoAs Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...
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Director, Clinical Regulatory Writing
hace 2 semanas
España AstraZeneca A tiempo completoLocation: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team...
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Associate Director, HR Project Management
hace 1 día
España Fresenius Medical Care A tiempo completoAssociate Director, HR Project Management (m/f/d)The Associate Director, HR Project Management is responsible for providing leadership and project management around approved Global HR Projects/Programs. This role oversees the operational aspects of projects and serves as liaison between project management, key stake holders, and HR functional owners....
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Regulatory Affairs Associate
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España Galderma Pharma S.A A tiempo completoRegulatory Affairs Associate With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...
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Regulatory Affairs Associate
hace 7 días
España buscojobs España A tiempo completoGlobal Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...
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Regulatory Affairs Associate
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España Global Life Science Hub A tiempo completoGlobal Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...
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[Oncology]Local Study Associate Director
hace 3 semanas
España AstraZeneca GmbH A tiempo completoAstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents,...
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Oferta de empleo de Associate Director, Project Management
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hace 1 semana
España Kyndryl A tiempo completoSenior Associate, Project Management - MadridWho We Are: At Kyndryl, we design, build, manage, and modernize the mission-critical technology systems that the world depends on every day. We are always moving forward – pushing ourselves to build a more equitable, inclusive world for our employees, customers, and communities.The Role: Kyndryl Project Managers...
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Regulatory Affairs Associate
hace 1 semana
España Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
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Regulatory Affairs Associate
hace 5 días
España Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
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Regulatory Affairs Associate
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España Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
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España Alantra Group A tiempo completoProject Management Associate - Capital Raising Unit (Madrid, Spain)Alantra is an independent global mid-market financial services firm providing investment banking, asset management, and private capital services to companies, families, and investors operating in the mid-market segment. The Group has over 650 professionals across Europe, the US, Latin...
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España Agilus Work Solutions A tiempo completoAgilus is recruiting for a Project Director in the Construction Industry in a hybrid work environment in GTA, Ontario.The Project Director is responsible for overseeing and managing large-scale infrastructure and industrial projects, ensuring that they are completed with the highest quality standards. This role involves strategic planning, financial...
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Chemical Regulatory Affairs Associate
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España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...