Associate Director, Translations Regulatory Submissions Project Management
hace 5 días
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
#J-18808-Ljbffr
-
Associate Director, Regulatory Affairs
hace 6 días
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...
-
Regulatory Affairs Associate Director
hace 6 días
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...
-
España AstraZeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...
-
Director, Clinical Regulatory Writing
hace 3 días
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...
-
Regulatory Affairs Associate
hace 6 días
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...
-
[Oncology]Local Study Associate Director
hace 6 días
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,...
-
España Zauma A tiempo completoAssociate Director, Project Management (Puesto para profesional con discapacidad) Anunciado 9 de agosto (Publicada de nuevo) Requisitos mínimos - Degree in business or scientific field (or Project Management related field)- Expertise in programme/project management, with a proven track record- Strong communication and relationship building skills...
-
Regulatory Affairs Associate
hace 6 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...
-
Project Management Associate
hace 6 días
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...
-
Project Director
hace 5 días
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...
-
Chemical Regulatory Affairs Associate
hace 6 días
España W. L. Gore & Associates, Inc A tiempo completoGore Associates, please login to view internal opportunities and refer candidates.Chemical Regulatory Affairs Associate (f/m/d)About the Role: We are looking for a Chemical Regulatory Affairs Associate (f/m/d) to join our Fabrics team. In this role, you will focus on EMEA chemical control regulations enabling the use, development, and movement of chemicals...
-
Regulatory and Start Up Specialist
hace 6 días
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...
-
Director of Project Management
hace 6 días
España Appspace A tiempo completoYour Role as the Director of Project Management: As the Director of Project Management, you will provide strategic leadership and direction across multiple, high-impact projects, ensuring alignment with the organization’s long-term vision and objectives. You will lead a team of project managers, overseeing the successful execution of project portfolios,...
-
Regulatory and Start Up Specialist
hace 6 días
España Precision Medicine Group, LLC. A tiempo completoRegulatory and Start Up Specialist - Clinical Trial ServicesLocation: Madrid, SpainJob Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision for Medicine is not your typical CRO. We have brought together new technologies, expertise, and operational scale to help the life sciences improve the...
-
España AstraZeneca A tiempo completoAssociate Director, Translational Medicine Drug Project ManagementThe Translational Medicine (TM) Oncology Drug Project Management group at AstraZeneca (AZ) is responsible for project and portfolio management to ensure the successful delivery of TM projects from strategy development to data and results delivery to the Global Project Teams (GPT). The group...
-
España AstraZeneca A tiempo completoAssociate Director, Platform Data Services – Evinova Join us on our journey to create the future of medicine at Evinova! We are currently seeking an Associate Director, Platform Data Services who will own the vision and roadmap for operational data across the Evinova Platform. This role is a unique opportunity to be a product owner for an agile team...
-
Senior Account Executive Translations
hace 4 semanas
España Innovative Trials A tiempo completoAbout Innovative Trials At Innovative Trials , we don't just lead the way in patient recruitment solutions—we redefine the patient journey As an award-winning and industry-recognised leader, we've built a reputation for not only delivering results but continuously pushing the boundaries of patient recruitment. We celebrate our wins, learn from our...
-
España Tbwa ChiatDay Inc 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...
-
España Prime Vigilance Ltd A tiempo completoSenior Associate/Specialist, Regulatory Intelligence and AnalyticsFull-timeDepartment: Regulatory Intelligence and AnalyticsWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North...
-
España Ergomed A tiempo completoSenior Associate/Specialist, Regulatory Intelligence and AnalyticsWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical...
