Clinical Trials Regulatory Lead
vor 2 Wochen
The Role
Clinical Trial Regulatory Lead
At Roche, we are committed to developing life-improving therapies worldwide. As a Clinical Trial Regulatory Lead, you will play a crucial role in shaping our regulatory strategy and submissions globally (excluding US, China, and Japan) for molecules and medical devices.
You will work closely with early research and development functions, affiliates, product development, and technical regulatory teams to develop and realize clinical trial submission strategies, build regulatory submissions, and deliver fit-for-purpose solutions to achieve our organizational goals and objectives.
In this dynamic and multifaceted environment, you will require strong global clinical trial regulatory knowledge, an innovative mindset, and a willingness to push boundaries to get patients faster access to treatments.
Your Key Responsibilities
- Provide expert advice and regulatory insights to the organization on external and internal requirements for clinical study procedures and monitor the regulatory landscape for changes.
- Lead the regulatory procedure for Clinical Studies submissions.
- Engage in dialogue with health authorities to ensure efficient approvals of submissions and shape the external regulatory environment.
- Lead clinical study submissions to Health Authorities globally (excluding US, China, and 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 of other team members.
- Identify and pursue opportunities to optimize the clinical study processes.
Your Requirements
- 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 judgment 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.
- 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 Trial Regulatory Lead
vor 1 Monat
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleClinical Trial Regulatory LeadAt Roche, we are committed to developing and maintaining the highest standards of regulatory excellence. As a Clinical Trial Regulatory Lead, you will play a critical role in shaping the regulatory strategy for our clinical trials, ensuring compliance with global regulations and guidelines.Your Key...
-
Regulatory Lead for Clinical Trials
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche Vollzeitbody {font-family: Arial, sans-serif;}Job SummaryWe are seeking a highly skilled Clinical Trial Regulatory Lead to join our team at Roche. As a key member of our Pharma Development Regulatory organization, you will be responsible for leading the clinical trial regulatory strategy and submissions globally (excluding the US, China, and Japan) for molecules and...
-
Clinical Trials Operations Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz IQVIA VollzeitClinical Trials Operations LeadWe are seeking a highly skilled Clinical Trials Operations Lead to join our team at IQVIA. In this role, you will be responsible for leading the Study Management Team and ensuring the regional/global coordination of clinical trial management activities.Manage clinical trial planning, execution, and closureLead the Study...
-
Clinical Trials Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the Role:We are seeking a highly skilled Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations team, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out phases.Your Key Responsibilities:Develop, lead, and...
-
Global Clinical Development Leader
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob DescriptionThe Global Program Clinical Head is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.This role owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a...
-
Clinical Trial Operations Specialist
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitTransforming Healthcare TogetherAt Roche, we're committed to pushing the boundaries of healthcare. As a Clinical Trial Partner, you'll play a key role in driving business performance improvements and shaping the future of clinical trials. About the RoleThis is an exciting opportunity to join our pRED Clinical Operations team, where you'll work at the cutting...
-
Neuroscience Clinical Development Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitKey ResponsibilitiesAs a Lead Medical Director in our Neuroscience Clinical Development team, you will play a crucial role in the late-stage development of our MS product. Your primary responsibilities will include leading the design, development, and execution of clinical studies, as well as collaborating with cross-functional teams to develop product...
-
Clinical Trials Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the Role:As a Senior Clinical Trials Manager at Neurocrine Biosciences, you will be responsible for leading the operational activities of assigned clinical studies, including planning, initiation, conduct, and close-out phases. You will work closely with cross-functional teams to develop and implement clinical trial strategies, manage multiple Contract...
-
Senior Clinical Development Director
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitRole Overview:As a Senior Clinical Lead at Ridgeline Discovery GmbH, you will drive our clinical development pipeline, working closely with program leaders, internal and external experts, and a Contract Research Organization (CRO) to design and implement clinical development strategies.Key Responsibilities:Clinical Development Strategy: Develop and execute...
-
Senior Clinical Development Director
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitSenior Clinical Lead Early Clinical Development Job DescriptionSixPeaks Bio, a leading biotechnology company, is seeking a highly skilled Senior Clinical Lead Early Clinical Development to drive the company's clinical development pipeline. As a key member of the team, you will be responsible for designing and implementing clinical development strategies,...
-
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout the RoleWe are seeking a highly motivated and experienced Senior Clinical Lead to join our team at Ridgeline Discovery GmbH. As a key member of our clinical development team, you will be responsible for driving our pipeline forward, working closely with program leaders, internal and external experts, and a CRO to design and implement clinical...
-
Senior Regulatory Affairs Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz headcount AG VollzeitJob Title: Senior Regulatory Affairs ManagerOur client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking a Senior Regulatory Affairs Manager to provide operational and strategic support for global regulatory activities across various phases, ensuring compliance with local and international regulations.Key...
-
Clinical Development Leader for Rare Diseases
vor 1 Woche
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitIronwood Pharmaceuticals is a leading global healthcare company dedicated to advancing the treatment of gastrointestinal (GI) diseases and redefining the standard of care for GI patients. As part of VectivBio, we are focused on discovering, developing, and commercializing innovative treatments for severe rare conditions with high unmet medical need.The...
-
Digital Biomarker Clinical Integration Specialist
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleWe are seeking a highly skilled Digital Biomarker Clinical Integration Manager to join our team at Roche Information Solutions. As a key member of our Digital Biomarker Chapter, you will play a crucial role in leveraging mobile technologies to collect objective and continuous sensor data from patients in clinical trials.Key ResponsibilitiesDevelop...
-
Clinical Development Strategist
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitJob DescriptionWe are seeking a highly motivated Senior Clinical Lead to drive our clinical development pipeline for obesity and cardiometabolic conditions. As a key member of our team, you will work closely with program leaders, internal and external experts, and a CRO to design and implement clinical development strategies.ResponsibilitiesAct as the...
-
Digital Biomarker Clinical Integration Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleWe are seeking a highly skilled Digital Biomarker Clinical Integration Manager to join our team at Roche Information Solutions.This is an exciting opportunity to contribute to the development of innovative digital remote monitoring concepts for sensitive and meaningful drug development endpoints.Develop and execute digital biomarker strategies to...
-
Global Neuroscience Medical Lead
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitAbout the RoleRoche is seeking a Clinical Development Director for Neuroscience to support the ongoing late-stage development of our MS product. This individual will lead the design, development, and execution of clinical studies and play an active role in health authority interactions.Key ResponsibilitiesLeading clinical studies and interacting with health...
-
Basel, Basel-Stadt, Schweiz Roche VollzeitJob OverviewWe are seeking an experienced Digital Biomarker Clinical Integration Manager to join our team at Roche. This is a unique opportunity to contribute to the development of innovative digital remote monitoring concepts and solutions.Your RoleYou will be responsible for executing our digital biomarker strategy, seamlessly integrating mobile sensor...
-
Senior Clinical Pharmacology Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout the PositionRidgeline Discovery GmbH is seeking a highly skilled Clinical Pharmacology Strategist to play a pivotal role in developing innovative therapies for obesity and cardiometabolic conditions.Key ResponsibilitiesDevelop and implement clinical pharmacology strategies to support drug development programs.Collaborate with cross-functional teams to...
-
Diagnostic Strategy Lead
vor 1 Monat
Basel, Basel-Stadt, Schweiz Bayer VollzeitTransforming Healthcare with PrecisionBayer is a global leader in the development of innovative diagnostic solutions. We are seeking a highly skilled Diagnostic Strategy Lead to join our team and contribute to the success of our Precision Medicine portfolio.Key Responsibilities:Develop and implement comprehensive diagnostic strategies to support clinical...