Clinical Trial Regulatory Lead

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz Roche Vollzeit

The Position

Clinical Trial Regulatory Lead 

The Pharma Development Regulatory (PDR) organization develops and maintains the licensees that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business to help them understand our products' clinical value. We also work across industry and regulators to continually evolve regulatory policy.

As a Clinical Trial Regulatory Lead (CTRL) you will lead the clinical trial regulatory strategy and submissions globally (ex US/China/Japan) for molecules and medical devices. The CTRL engages across the early research and development functions (REDs), affiliates, product development and technical regulatory to develop and realize clinical trial submission strategies, build regulatory submissions and deliver fit-for-purpose solutions to achieve organizational goals and objectives.

A CTRL also enables the development of organizational and people capabilities of the future. CTRLs lead, contribute to, and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule enabling portfolio.

The CTRL sits in a dynamic and multifaceted environment and requires strong global clinical trial regulatory knowledge (both for molecule and medical devices), an innovative and experimental mindset and willingness to push the boundaries to get patients faster access to treatments.

In this position you:

Provide expert advice and regulatory insights to the organization on external and internal requirements for clinical study (molecule and device) procedures and monitor the regulatory landscape for changes

Lead the regulatory procedure for Clinical Studies (molecule and device) submissions 

Engage in dialogue with health authorities to ensure efficient approvals of submissions and shape the external regulatory environment 

Lead clinical study (molecule and device) submissions to Health Authorities globally (ex US, China, Japan) including strategy, compilation and lifecycle management

Lead/Participate in cross-organizational/enterprise level projects and initiatives

Partner with global policy to shape the external regulatory environment 

Invest in your own learning and development, in addition to coaching and mentoring the development other team members 

Identify and pursue opportunities optimizing the clinical study (molecule and device) processes.

You are someone to bring the following knowledge, skills and abilities:

You are keen to develop regulatory insights through your experience, regulatory and scientific knowledge to determine solutions and solve problems. You demonstrate the ability to assess priorities and pivot as required and set strategies to align with dynamic business and environment needs. You seek improvements (including digital solutions) in work processes while using judgement to balance creativity with compliance and the requirement to meet timelines.

You influence directly or indirectly the internal and external health authorities, CROs, IVD manufacturers) stakeholders on more than one level who may have different interests or goals to reach consensus and achieve team objectives .You are able to communicate effectively in a multicultural, multi-functional environment. You are able to lead teams through submission activities to meet critical timelines and goals CTR)

You work effectively to share responsibility as a team member in a customer focused environment. You share information, knowledge and guidance mentoring and onboarding new team members). You approach work with a positive and curious attitude.

Knowledge and proven expertise in EU clinical trial regulation/IVDR and other relevant clinical trial and device regulatory legislation and guidelines in Europe and of key International countries (as well as other countries) in order to support global clinical studies. Good knowledge of GCP principles applied globally. Working knowledge of Clinical Trial Information System (CTIS) and the Veeva vault systems (specifically the regulatory vault) is an advantage.

  • Clinical Science Trial Leader

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz C028 (FCRS = CH028) Novartis Pharma AG Vollzeit

    Clinical Science Trial Leader page is loadedClinical Science Trial LeaderApply locations Basel (City) time type Full time posted on Posted 30+ Days Ago job requisition id REQ-10020427BandLevel 4Job Description SummaryAs a Clinical Trial Leader you will be leading the global multidisciplinary matrix Clinical Trial Team (CTT) to ensure all trial deliverables...

  • Scientist in Clinical Trials

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    About the Role:Clinical Trial Scientists at CTC Resourcing Solutions are responsible for ensuring the successful execution of clinical trials. This involves developing and maintaining a deep understanding of trial science and medicine, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.Main Responsibilities:Key...

  • Clinical Trial Associate

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Prime Life Sciences Vollzeit

    To strengthen our team in Switzerland, we are looking for a Clinical Trial Associate who will support our customers' clinical trial. In this role, you will support our clients on the coordination, data sampling and documentation management.Your Duties Tracking and reporting trial documents Updating clinical trial databases Prepare, collate, distribute and...

  • Clinical Trial Team Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz C028 (FCRS = CH028) Novartis Pharma AG Vollzeit

    About the RoleWe are seeking an experienced Clinical Science Leader to join our team and lead the global Clinical Trial Team to ensure all trial deliverables are met.The ideal candidate will have approximately 2+ years' experience in clinical trials/development and a strong understanding of oncology/hematology.The selected candidate will be responsible for...

  • Clinical Trial Logistics Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz RM IT Services GmbH Vollzeit

    Senior Clinical Supply Chain PositionWe are seeking a highly experienced Clinical Supply Chain Specialist to join our team at RM IT Services GmbH. As a senior member of our Clinical Trial Team, you will be responsible for leading the development and implementation of clinical supply strategies to support the success of our pharmaceutical clients.Your Key...

  • Clinical Trials Strategy Leader

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    About Strategic LeadershipThis Clinical Trials Strategy Leader role will be responsible for developing and delivering a comprehensive strategy to drive successful delivery of our clinical portfolio. You will lead and manage the early development clinical portfolio, overseeing the strategy, planning, and execution of all clinical programs.About the...

  • Clinical Trial Expert

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job Description:The Life Science Career NetworkCareer opportunities in clinical trials are available at CTC Resourcing Solutions, a company specializing in HR and consulting services for the life sciences industry.We have an innovative Swiss bio-pharmaceutical client seeking a Clinical Trial Scientist for a 12-month contract in the Basel area.Main...

  • Research Scientist

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Responsibilities:Clinical Trial Scientists at CTC Resourcing Solutions are responsible for several key activities including collaboration with cross-functional teams, development and maintenance of trial science and medicine knowledge, and ensuring compliance with regulatory requirements.Main Responsibilities:Key Tasks:Collaborate with Clinical Project...

  • Global Clinical Lead

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Global Clinical Lead PositionJoin our team at Novartis as a Global Clinical Lead and contribute to the development of life-changing oncology therapies. This is an exciting opportunity to work on the cutting edge of medical innovation.As part of our Translational Clinical Oncology division, you will collaborate with experts from various fields to design and...

  • Supply Chain Manager Clinical Trials

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz RM IT Services GmbH Vollzeit

    Pharmaceutical Supply Chain RoleWe are seeking an experienced Supply Chain Manager Clinical Trials to join our team at RM IT Services GmbH. As a critical member of our Clinical Trial Team, you will be responsible for designing and implementing effective clinical supply strategies to support the success of our pharmaceutical clients.Your Key...

  • Clinical Program Leader

    vor 22 Stunden

    Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association Vollzeit

    Job OverviewThe Healthcare Businesswomen's Association is looking for a Senior Medical Expert for Clinical Operations to join our team. As a key member of our clinical development team, you will be responsible for leading the strategic planning and management of clinical programs from an end-to-end clinical operations perspective.Key ResponsibilitiesLead the...

  • Clinical Development Leader

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz C028 (FCRS = CH028) Novartis Pharma AG Vollzeit

    The role of a Clinical Development Leader is to oversee the development and execution of clinical strategies for global programs.As a key member of the Global Clinical Team, you will be responsible for leading the design, implementation, and execution of clinical trials across multiple indications and compounds.Your responsibilities will include:Leading...

  • Clinical Trial Logistics Coordinator

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Hobson Prior International Ltd Vollzeit

    We are looking for a highly organized Clinical Trial Logistics Coordinator to join our team. In this role, you will be responsible for managing the supply chain for clinical trials, ensuring timely delivery and compliance with regulations.Duties and Responsibilities:Coordinate packaging, distribution, and documentation processes to ensure seamless supply...

  • Clinical Trials Logistics Coordinator

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job OverviewCTC Resourcing Solutions is seeking a talented Commercial Packaging and Clinical Trial Supplies Manager to support our clients in the pharmaceutical industry.The successful candidate will be responsible for managing the end-to-end supply chain for clinical trials, from packaging development to distribution and returns.This role requires strong...

  • Strategic Operations Leader for Clinical Trials

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association Vollzeit

    We are looking for a Strategic Operations Leader for Clinical Trials to join our team at the Healthcare Businesswomen's Association. In this role, you will be responsible for developing and implementing strategic plans for clinical trials, ensuring effective operational execution and delivery.Key AccountabilitiesAs the Strategic Operations Leader, you...

  • Clinical Packaging Lead

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Clinical Packaging LeadCompany Overview:Coopers Group AG is a leading pharmaceutical company that specializes in the development and manufacturing of high-quality products.Job Description:The Clinical Packaging Lead will play a crucial role in ensuring the quality and compliance of packaging materials used in our clinical trials.Key Responsibilities:Review...

  • Clinical Trial Coordinator

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz CTC Vollzeit

    About the RoleWe are looking for an experienced Clinical Trial Scientist to support the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific and operational perspective.The successful candidate will have previous authoring/co-authoring of clinical trial protocols, ICFs, scientific trial-related documents...

  • Clinical Trial Scientist

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Our client, an innovative Swiss bio-pharmaceutical company focused...

  • Clinical Program Leader

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    6000 That's the number of associates in the BioMedical Research (BR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patientsBased on our understanding of cancer at the molecular, cellular and organismal levels, Translational Clinical Oncology or...

  • Clinical Trial Expert

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Actalent Vollzeit

    Overview:We are seeking a highly skilled Clinical Trial Expert to join our team at Actalent. In this role, you will collaborate closely with the Clinical Project Scientist on trial-related activities, developing a deep understanding of the science and medicine related to the trial.Job Responsibilities:Collaborate with the Clinical Project Scientist to ensure...