Manager, Clinical Trial Regulatory Lead

Vor 4 Tagen

Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG Vollzeit

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

Objective / Purpose:

  • Develops the operational implementation plan for clinical trial applications (CTAs) in EUCAN and GEM regions from initial submission throughout lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products and neuroscience.
  • Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda's global and regional internal procedures.
  • Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead. Works in collaboration with CRO to ensure compliance.

Accountabilities:

  • Demonstrates Takeda leadership behaviors.
  • Collaborates with Takeda Global and Regional counterparts, as applicable to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle.
  • May present regional CTA regulatory strategies to leadership/senior management
  • Identifies regional/national requirements to support submissions of CTAs to Regulatory Authorities.
  • Coordinates submission preparations process and creation of administrative documents to support initial CTAs and/or maintenance submissions (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate.
  • Develops and maintains standardized communication/tracking/planning tools and templates for internal use.
  • Ensures accurate and timely submissions and communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.).
  • Provides regulatory oversight of CRO activities as applicable to ensure that all submissions activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., eTMF).
  • Supports non routine submission activities and deviation follow-up as needed (e.g., provision of Serious Breach submissions, submission of inspection reports, ad-hoc unexpected filings etc.).
  • Upon request, provides ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials.
  • Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with senior team member and/or Global/EU Regulatory Lead, as applicable.
  • Supports the maintenance of appropriate internal knowledge base on emerging information and trends with regulators for clinical trials.
  • Participates, as appropriate, and authors/reviews internal procedures and processes.

Education & Competencies (Technical and Behavioral):

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience.
  • A minimum of 4 years of experience in drug regulatory affairs preferably within the EU/GEM region.
  • Experience with EU CTR will be advantageous.
  • Solid regulatory experience, including knowledge of CTA regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)].
  • Has basic regulatory procedure knowledge with major health authorities in the region.
  • Analyzes issues with attention to detail and makes reasoned recommendations.
  • Promotes an inclusive culture and expresses empathy for others.
  • Is able to carry out assigned activities within reasonable time.
  • Adapts to changing circumstances and is able to build and maintain relationships.
  • Receives and gives feedback; expresses ideas, questions, and disagreement.
  • Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
  • Fluency in English.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool

Learn more at

LocationsZurich, Switzerland
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time

  • Manager, Clinical Trial Regulatory Lead

    vor 2 Wochen

    Zürich, Zürich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? Objective / Purpose_:_ _ Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes in...

  • Manager, Clinical Trial Regulatory Lead

    vor 2 Wochen

    Zürich, Zürich, Schweiz ARIAD Vollzeit

    Job Type:Full TimeJob Level:SeniorTravel:Minimal (if any)Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.At Takeda, we strive to provide transformational opportunities for...

  • Clinical Trial Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Denali Therapeutics Vollzeit

    Clinical Trial Manager***Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.The OpportunityThe Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies to ensure...

  • Clinical Trials Lawyer

    vor 2 Wochen

    Zürich, Zürich, Schweiz Axiom Vollzeit

    We are currently seeking Clinical Trial Lawyers (m/f/d) to work with various Axiom clients across all industries anywhere in Switzerland. Responsibilities : Provide advice and counsel on a range of legal matters pertaining to Clinical Trial Activities, Research & Development, and related activities. Draft, review and negotiate a variety of contracts...

  • Clinical Bioanalysis Project Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Takeda Pharmaceutical Vollzeit

    People First - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. Our people are the heart of Takeda.For our Vaccine Business Unit in Zurich, we are looking for aClinical Bioanalysis Project Manager (M/F/d)in a...

  • Clinical Trial Manager in Psychiatry for Eu Horizon

    vor 2 Wochen

    Zürich, Zürich, Schweiz Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich Vollzeit

    Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich_Clinical trial manager in psychiatry for EU Horizon project TRUSTINGYour profile: Degree in epidemiology, medicine, public health or a related field Certificate of Advanced Studies (CAS) in Clinical Trial Management Certificate in Good Clinical Practice Experience with...

  • Clinical Research Associate

    vor 2 Wochen

    Zürich, Zürich, Schweiz Novo Nordisk AS Vollzeit

    Are you committed, do you enjoy working independently and do you always maintain an overview? Then we are looking for you to support our Clinical Research Team at Novo Nordisk Pharma AG As a Clinical Research Associate (CRA) working with Novo Nordisk, you will have the opportunity to make a difference to patients' lives across a broad spectrum of...

  • Clinical Evaluation Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz BIOTRONIK SE & Co. KG Vollzeit

    Clinical Evaluation Manager (100%)As one of the world ́s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world...

  • Clinical Director, Clinical Research

    vor 2 Wochen

    Zürich, Zürich, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we 'follow the science' and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Project Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz SIVA Health AG Vollzeit

    SIVA Health AG is a digital health startup company in the field of sound-based respiratory diagnostics, located in Zurich, Switzerland. Through collaboration with global corporate partners, clinics, and researchers, we at SIVA Health have developed a novel device to continuously measure cough (24/7). This innovation is currently being used in global clinical...

  • Clinical Research Associate

    vor 2 Wochen

    Zürich, Zürich, Schweiz Novo Nordisk Vollzeit

    Are you committed, do you enjoy working independently and do you always maintain an overview? Then we are looking for you to support our Clinical Research Team at Novo Nordisk Pharma AGAs a Clinical Research Associate (CRA) working with Novo Nordisk, you will have the opportunity to make a difference to patients' lives across a broad spectrum of therapeutic...

  • QA Manager Clinical GCP audits and compliance

    vor 2 Wochen

    Zürich, Zürich, Schweiz gloor & lang ag life science careers Vollzeit

    Our customer is a R&D driven biopharmaceutical company located in Zurich. Focused on Immune Response diseases. Our client develops exciting new MAbs and partners with big pharma in clinical development. For further support with the growing QA activities we seek to recruit an experienced QA person, familiar with GCP audit activities. The position is defined...

  • Clinical Project Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz SIVA Health AG Vollzeit

    SIVA Health AG is a digital health startup company in the field of sound-based respiratory diagnostics, located in Zurich, Switzerland. Through collaboration with global corporate partners, clinics, and researchers, we at SIVA Health have developed a novel device to continuously measure cough (24/7). This innovation is currently being used in global clinical...

  • QA Manager Clinical GCP – audits and compliance

    vor 2 Wochen

    Zürich, Zürich, Schweiz gloor&lang AG Vollzeit

    12 months Contractor role in Zurich--- |Our customer is a R&D driven biopharmaceutical company located in Zurich. Focused on Immune Response diseases. Our client develops exciting new MAbs and partners with big pharma in clinical development. For further support with the growing QA activities we seek to recruit an experienced QA person, familiar with GCP...

  • Clinical Affairs Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Sonova AG Vollzeit

    Who we areIn a life without sound, our work provides meaning.As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced...

  • Clinical Affairs Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Sonova Vollzeit

    Who we areYou enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team.Above all, you want your work to matter: Welcome to our world At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable...

  • Associate Director, Clinical Regulatory

    vor 2 Wochen

    Zürich, Zürich, Schweiz Denali Therapeutics Vollzeit

    Associate Director, Clinical RegulatoryDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.The OpportunityResponsibilities Accountable for developing and implementing regulatory strategy for complex development...

  • Werkstudent Clinical

    vor 2 Wochen

    Zürich, Zürich, Schweiz BIOTRONIK SE & Co. KG Vollzeit

    Werkstudent Clinical (40%)As one of the world ́s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of...

  • international regulatory affairs

    vor 2 Wochen

    Zürich, Zürich, Schweiz gloor & lang ag life science careers Vollzeit

    Our client is an R&D driven biotech company based in in Zurich. The further growth needs the support of a Sr. Provide strategic regulatory guidance to cross-functional teams (R&D, Clinical and Quality) during drug development stages As a Senior RA Manager you are responsible for proactive and efficient management of all regulatory aspects for the assigned...

  • QA Manager Clinical GCP – audits and compliance

    vor 2 Wochen

    Zürich, Zürich, Schweiz gloor&lang AG Vollzeit

    12-month Contractor Role in ZurichOur client, a research and development-driven biopharmaceutical company based in Zurich, specializes in Immune Response diseases and collaborates with major pharmaceutical companies for clinical development. To support the expanding Quality Assurance (QA) activities, we are looking to hire a skilled QA professional familiar...