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Roche

Regulatory Talent Pool - TOPRA EVENT

Thank you for taking an interest in Global Regulatory at Roche. If you are interesting in working with us in the future please apply to this talent pool. We will keep your details and be in touch with you about future and current opportunities.

Therefore please add a cover letter with your CV explaining:

  • why you want to join roche

  • what area(s) of Global Regulatory you are interested in and why and

  • why Roche

Whilst in this Talent Pool you are not applying directly to a specific role so please continue to have a look at the various opportunities we have within Regulatory HERE: https://go.roche.com/RegulatoryJobs 

Please also feel free to reach out to Fiona Mcfarlane (fiona.mcfarlane@roche.com) who is the Talent Acquisition Specialist for Regulatory.

Global Regulatory Programme Management

We work with cross functional global teams bringing new medicines from entry-into-human studies through to licensure and post marketing in Europe, USA, China and markets worldwide. 
Roles range from entry level graduate trainees to senior roles with global product and portfolio accountability. As your experience and leadership skills grow, Roche offers you the opportunity to grow your career.  
From the Roche Welwyn development site in the UK, you will work with colleagues around the world, in other development sites in Switzerland, the US, Canada, China and Japan as well as with local regulatory colleagues in our affiliate offices.

Example Roles in the UK

  • Global Regulatory Leader:  A key role, accountable for the global regulatory strategy and deliverables for a molecule. This person is the senior regulatory representative on global development teams and leads the regulatory affairs sub team.

  • EU partners:  With roles from entry level associate to principal partners taking increasing responsibility to lead and drive the regulatory strategy and deliverables for the EU. Working closely with global regulatory leads, other regulatory colleagues and cross functional teams you could be working on a NME filing, a line extension, supporting post marketing activities or early development projects.


Regulatory Documentation

Global Documentation is responsible for preparing regulatory documents to meet the evolving needs of Health Authorities using our expertise in writing, science and regulatory requirements.​ We have staff located in Basel, Welwyn, Mississauga and San Francisco.

Our global team of regulatory documentation scientists work with multiple departments throughout the organization providing end to end support of regulatory documents supporting the development and/or maintenance of our product licenses worldwide. 

Example Roles in the UK

  • Entry level graduate trainees and associates support activities e.g preparation of clinical and safety documents such as DSURs, IBs, CSRs for submission to Health Authorities, 
  • Functional managers provide direction and leadership to regulatory documentation scientists and functional expertise to initiatives and activities across Roche 
  • Team Leaders lead a global matrix team of documentation scientists and providing strategic oversight for the preparation of clinical and safety documents within a therapeutic area or within a particular stage of development.


Global Regulatory Labeling

Our vision is to ensure consistent and safe use of medicines in the global health care environment through the development of high quality labels.​ We maintain and develop the global company core datasheet and have staff located in  Roche’s global development sites in Basel, Welwyn, Mississauga and San Francisco. 
As a member of our team in Welwyn, you can build bridges globally through interactions with local regulatory affiliates (90+ countries) and other Roche international development sites.
As your experience grows there are opportunities to mentor junior team members and lead department initiatives.


Example Role in the UK

As the labelling strategist you will be creating core data sheets for innovative medicines that directly support healthcare professionals with their clinical decision-making.  You have the opportunity to engage with expert multi-function project teams throughout the clinical development and commercial lifecycle of first/best in class medicines.  Using your strategic labelling knowledge you drive the development of the core data sheet mapping out labelling risks and opportunities.

Regulatory Business Office

The Regulatory Business Office comprises a diverse group of functions providing support, guidance and framework  to the business in areas such as :

  • Quality management and compliance to GCP/GVP requirements; 
  • Non-molecule Portfolio Management and Change Management; 
  • Budget planning and Organizational Capability Development; 
  • Direct and in-direct Project Management to ensure successful global filing and reviews;
  • Disclosure of clinical trial protocols and results through data sharing; 
  • Developing and managing the systems and tools needed to support the function effectively and efficiently


Example Roles in the UK

  • Global Regulatory Project Manager: working with cross-functional filing teams to define and execute regulatory filing strategies enabling successful global filings and Health Authority interactions.
  • Initiative Project Manager: working on strategic initiatives evolving ways of working and capabilities to meet future needs.
  • Quality and compliance Manager: supporting our global regulatory groups and affiliates worldwide to build compliance into their day to day work.
  • Disclosure Manager working to ensure timely postings of clinical study protocols and results in line with global requirements; 
  • Technology Business Manager: leading the development and implementation of systems and processes. 

Clinical Trial Regulatory Management

The Clinical Trials Coordinator closely collaborates with the Global Regulatory Program Manager in the preparation of Clinical Trial Application Dossiers.
Working in cross-functional global teams, we support the regulatory submission of global clinical trials conducted in the EEA, China and other Key International Countries. Members of our CTRM team are located in Basel (Switzerland) and Welwyn (UK).
Roles range from junior level to senior level with increasing responsibility. The CTRM Group Manager  leads groups of Clinical Trial Associates and Coordinators.

Example Roles in the UK

  • Clinical Trials Coordinator: works in cross-functional global teams, provides support to the Regulatory Program Manager on the overall management of Clinical Trials Applications in EEA and Key International Countries. Can develop ownership of a particular business process or subject matter expert in the area of Clinical Trial Applications.
  • Senior Clinical Trials Coordinator: contributes to change management and global initiatives in the organization. Has extended responsibilities in the coordination of Clinical Trial Applications within global teams and can have Business Process ownership or be a subject matter expert in the area of Clinical Trial Applications.
  • CTRM Group Manager:  includes line management responsibilities, leads cross-functional initiatives and represents the CTRM group within and outside the regulatory department. May be a Global Process Owner for Clinical Trial Applications and related processes.


International Regulatory

A patient is a patient regardless of where they live. The International Regulatory group supports our local regulatory colleagues across more than 100 countries to bring Roche innovative medicines to patients. We are the champion and voice of our affiliates within the global organization and we ensure this voice is heard when product teams are making strategic decisions.
Unlocking the power of our connections with colleagues globally is what makes us tick. As a member of Welwyn, UK-based International Regulatory group your contribution will be felt by patients across the globe. We work with Supply, Commercial, Legal, Product Development and Established Product teams to maximize this impact. You will be developing a unique appreciation of the regulatory landscape in regions that are central to the growth of the business.


Example Roles in the UK

  • International Product Partners are responsible for Roche portfolio products and work with the global and affiliate stakeholders to ensure regulatory plans are designed and executed. 
  • Regional Managers are responsible for geographic areas, support a wide range lifecycle activities for all products in the area. 
  • Regional Labelling Specialists support the array of labelling needs.

These three distinct roles work closely and flexibly as a team across all global regions and across the entire product portfolio. Consequently our team members are exposed to aspects of all the roles which offers many unique development opportunities.  


 

Roche is an equal opportunity employer.

Vocational & Development Programs, Vocational & Development Programs > Development Program

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