Regulatory Procedural Management and Clinical Trial Lead

Vor 5 Tagen

Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About Daiichi Sankyo Europe

Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life for patients worldwide.

Our Mission

We strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and protecting people from cardiovascular disease, the leading cause of death in Europe.

The Role

We are seeking a highly qualified Senior Director to lead our Regulatory Procedural Management and Clinical Trial Office in Europe and AMELA (Australia, Middle East, Eastern Europe, Latin America, Africa). This role will provide regulatory leadership, guidance, project management, and procedural-focused strategy and support to assigned projects in a manner that is scientifically sound, commercially viable, and in accordance with regulatory standards.

Key Responsibilities

  • Lead the Regulatory Procedural Management and Clinical Trial Office in the EU & AMELA, serving as a link between Regulatory Strategists, and other disciplines inside RA (e.g. Labelling, RegOps, Affiliates, CT office) and in R&D and in the business units.
  • Provide managerial and regulatory procedural guidance and operational strategy for development projects and marketed products in the EU & AMELA.
  • Manage and oversee the Clinical Trial Office Team in the EU to ensure smooth regulatory applications of clinical trials and regulatory clinical trial compliance in the EU.
  • Lead assigned non-project tasks designed to enhance the functionality and processes of RA.
  • Mentor and provide guidance to internal and external reports, including members of consultants and vendors.

Requirements

  • Master's degree in pharmacy, medicine, life or natural science; PhD preferred.
  • Post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization is a plus.
  • Deep knowledge of Global and European laws, regulations, guidelines in EU, US, and Japan and other requirements for human medicinal product marketing authorization and maintenance is essential.
  • Working experience in pharmaceutical industry, in Clinical Research Organizations or in a regulatory authority with at least 10 years of experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new global marketing applications (EU and non-EU) and major regulatory submissions and supplemental amendments/major variations.
  • Excellent interpersonal leadership and communication skills, with the ability to communicate and work across functions effectively in a multinational organization to accomplish results.
  • Computer proficiency (e.g. MS office, document management systems, databases) and excellent written and verbal communication skills in English, German, and a third language preferred.

  • Director of Regulatory Affairs and Clinical Trials

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Position Overview:The Senior Director role is pivotal in steering regulatory initiatives, offering strategic guidance, and managing projects with a focus on procedural excellence within the realm of clinical trials. This position demands a comprehensive understanding of regulatory frameworks and a commitment to maintaining high standards of compliance.Key...

  • Director of Regulatory Affairs and Clinical Trials

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Position Overview:The Senior Director of Regulatory Affairs and Clinical Trials will spearhead regulatory strategy, oversight, and project management to ensure compliance with industry standards while driving scientific and commercial success. This role encompasses leading the Regulatory Procedures and Project Management team, offering managerial guidance to...

  • Regulatory Affairs Specialist

    vor 9 Minuten

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to making a...

  • Regulatory Affairs Specialist

    vor 4 Minuten

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to making a...

  • Clinical Research Associate

    vor 2 Wochen

    Munich, Bayern, Deutschland Novotech Clinical Research GmbH Vollzeit

    About Novotech Clinical Research GmbHWe are a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.Our ExpertiseWe offer a comprehensive suite of services including:Regulatory Expertise: Ensuring compliance with regulatory...

  • Lead Clinical Trial Specialist

    vor 4 Wochen

    Munich, Bayern, Deutschland Meet Vollzeit

    Exciting Career Opportunity: Lead Clinical Trial SpecialistAre you driven by a desire to innovate within the healthcare sector and make a meaningful difference in patients' lives?Join our dedicated team at Meet as a Lead Clinical Trial Specialist, where you will be instrumental in navigating small to medium biopharmaceutical organizations through the...

  • Lead Clinical Trial Specialist

    vor 4 Wochen

    Munich, Bayern, Deutschland Meet Vollzeit

    Exciting Career Opportunity: Lead Clinical Trial SpecialistAre you driven by a desire to enhance healthcare and make a meaningful difference in patients' lives?Join our innovative team as a Lead Clinical Trial Specialist (LCTS), where you will be instrumental in assisting biopharmaceutical organizations in navigating the intricate process of clinical trials,...

  • Director of Regulatory Affairs and Clinical Trials

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Director of Regulatory Affairs and Clinical Trials (m/f/x), Regulatory Affairs EuropePosition Overview:This Senior Director role is designed to deliver regulatory expertise, strategic guidance, and project oversight for designated initiatives, ensuring alignment with scientific integrity and commercial feasibility while adhering to regulatory requirements....

  • Director of Regulatory Affairs and Clinical Trials

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Director of Regulatory Affairs and Clinical Trials (m/f/x), Regulatory Affairs EuropePosition Overview:This Senior Director role is pivotal in delivering regulatory expertise, strategic direction, and project oversight to designated initiatives, ensuring alignment with scientific integrity and commercial viability while adhering to regulatory frameworks. Key...

  • Director of Regulatory Affairs and Clinical Trials

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Director of Regulatory Affairs and Clinical Trials (m/f/x), Regulatory Affairs EuropePosition Overview:This Senior Director role is designed to deliver regulatory expertise, strategic guidance, and project oversight to various initiatives, ensuring compliance with industry standards while maintaining scientific integrity and commercial viability. Key...

  • Clinical Trials Project Coordinator

    vor 4 Wochen

    Munich, Bayern, Deutschland Scienta Vollzeit

    Junior Project Manager in Clinical Research (Oncology)Location: Germany (Candidates can be located anywhere in Germany. Please note that relocation or sponsorship cannot be provided for this role).About ScientaScienta is a pioneering organization in the field of oncology research, committed to advancing innovative treatments and transforming cancer care. As...

  • Clinical Trials Manager

    Vor 4 Tagen

    Munich, Bayern, Deutschland EPM Scientific Vollzeit

    About the RoleWe are seeking a highly skilled Clinical Trials Manager to join our team at EPM Scientific. As a key member of our clinical development team, you will be responsible for the management and coordination of clinical trials in the Neurology field.Key ResponsibilitiesManage and coordinate clinical trials from planning to completionDevelop and...

  • Clinical Trials Manager

    Vor 4 Tagen

    Munich, Bayern, Deutschland EPM Scientific Vollzeit

    About the RoleWe are seeking a highly skilled Clinical Trials Manager to join our team at EPM Scientific. As a key member of our clinical development team, you will be responsible for the management and coordination of clinical trials in the Neurology field.Key ResponsibilitiesManage and coordinate clinical trials from planning to completionDevelop and...

  • Clinical Trial Manager

    Vor 5 Tagen

    Munich, Bayern, Deutschland EPM Scientific Vollzeit

    About EPM ScientificWe are a leading scientific recruitment agency, dedicated to connecting talented professionals with exciting opportunities in the life sciences industry.Job SummaryWe are seeking an experienced Clinical Trial Manager to join our client's team in the Neurology field. As a Clinical Trial Manager, you will be responsible for the planning,...

  • Clinical Trial Manager

    Vor 6 Tagen

    Munich, Bayern, Deutschland EPM Scientific Vollzeit

    About EPM ScientificWe are a leading scientific recruitment agency, dedicated to connecting talented professionals with exciting opportunities in the life sciences industry.Job SummaryWe are seeking an experienced Clinical Trial Manager to join our client's team in the Neurology field. As a Clinical Trial Manager, you will be responsible for the planning,...

  • Clinical Research Trial Coordinator

    vor 1 Woche

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job SummaryAs a Clinician Services Engagement Associate at WCG Clinical, you will play a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with the project-specific scope of work.Key ResponsibilitiesPartner with external customers, such...

  • Clinical Research Trial Coordinator

    Vor 5 Tagen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job SummaryAs a Clinician Services Engagement Associate at WCG Clinical, you will play a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with the project-specific scope of work.Key ResponsibilitiesPartner with external customers, such...

  • Clinical Research Trial Coordinator

    Vor 7 Tagen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job SummaryAs a Clinician Services Engagement Associate at WCG Clinical, you will play a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with the project-specific scope of work.Key ResponsibilitiesPartner with external customers, such...

  • Clinical Research Trial Coordinator

    Vor 5 Tagen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job SummaryAs a Clinician Services Engagement Associate at WCG Clinical, you will play a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with the project-specific scope of work.Key ResponsibilitiesPartner with external customers, such...

  • Clinical Trial Services Associate, Germany

    vor 4 Wochen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    JOB SUMMARY: The Clinical Engagement Specialist plays a crucial role in facilitating communication and coordination between clinical research sites and internal teams to ensure the successful execution of clinical assessments in line with project-specific requirements. The ideal candidate will deliver exceptional customer service and guarantee that all...