Regulatory Program Manager

United Kingdom, Hertfordshire, Welwyn
Switzerland, Basel-City, Basel

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We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Who we are

We’re innovation, curiosity and diversity – multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we’re constantly learning and growing – and seeking people who share these goals. Here at our UK Welwyn site, we have 1006 people in the Global Pharma Development side of the business, 115 of these belong to our Regulatory function. Our Welwyn site has been continuously growing and developing on a Global scale for years. We are building strong connections worldwide and looking for individuals who can join us on our journey. 

Change has been a constant companion in the recent years. Professional know-how, methodological knowledge, consulting competence as well as social and personal skills are therefore becoming increasingly important success factors, especially for specialists and managers. 

We strongly believe that you as an employee are at the centre of your development. 

Development is about learning – and this can happen everyday. By intentionally deciding to do small things differently every day, you learn quicker, which can increase your impact in your current role and help you better prepare for future roles as well. It is up to you to decide how you want to integrate development into your daily work and Roche support all staff in their long term development of knowledge and skills. We offer further career opportunities locally and globally such as rotations into other departments and roles where people demonstrate talent and aptitude. 

The Opportunity

We currently have an opportunity for an EU Regulatory Program Manager to join our global team working primarily on our Oncology portfolio.

Working independently, as well as within a regulatory sub-team, you will participate in and represent the regulatory function on cross-functional teams in early and/or late stage projects, giving strategic regulatory input to those teams through a drug’s development and lifecycle.

You will support or lead interactions with Health Authorities in the EU and other key countries.  That will include the preparation of registration documents for centralized MAA/variations, core dossiers for CTAs and briefing packages for Scientific Advice and Qualification Advice. You may also support registration activities in key countries outside of the EU.

As the primary interface with Affiliate Regulatory Affairs, you will ensure Affiliates are informed of project developments and activities and you will work with your global team to provide responses to Regulatory questions from Affiliates.

We support our staff in the development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.

Who are we looking for?

  • We are looking for a highly motivated and committed individual who has broad regulatory knowledge and the experience and ability to manage complex issues with meticulous efficiency.
  • As a Regulatory Affairs professional, you should bring a very good level of experience in regulatory science and clinical drug development, e.g. sound knowledge of EU legislation, guidelines and procedures, successful management of regulatory submissions and procedures, direct interaction with Health Authorities (EMA/CHMP and national) and strategic regulatory input in drug discovery and development, especially clinical aspects.
  • We are looking for strong leadership competencies, so you should be an agile strategic thinker with exceptional communication skills at all levels and the ability to work effectively both within a team environment and independently.  You should be able to influence teams and functions in defining global development strategies.
  • You should have a University or higher degree in a scientific or technical discipline. Ideally you will have experience within Oncology. Paediatric development experience would be a plus.
  • You will be fluent in both written and spoken English, with an awareness of working globally.
  • If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.

To be considered for this position, please apply using the link below. When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs