Senior Regulatory Program Manager - I2ON
This role is open in the following locations:
- UK, Welwyn
- Switzerland, Basel
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.
We currently have an opportunity for an exceptional senior Regulatory Programme Manager to join our global I2ONE (immunology, infectious disease, ophthalmology, neurosciences and established products) group within Regulatory Programme Management.
Working independently, as well as within a regulatory sub-team, you will participate in and represent the regulatory function on cross-functional global teams in early and/or late stage projects. You will contribute to the global clinical drug development plan through a drug’s development and lifecycle. Specifically, you will lead the successful execution of filings, coordinating and/or leading cross functional teams in the development and implementation of regulatory strategies for the development of Roche products in the EU and other key countries.
You will lead interactions and negotiations with Health Authorities for Roche drug development programmes and project issue management in these countries for CTAs, Scientific Advice and Qualification Advice and/or for MAA/variations. You will lead the resolution of internal conflicts and manage stakeholders within the regulatory subteam and in the cross-functional organization.
You will be accountable for the development of key regulatory communications for Health Authorities and internal stakeholders for a programme.
As the primary interface with Affiliate Regulatory Affairs, you will ensure Affiliates are informed of project developments and activities, enabling dialogue and their contribution in all relevant project/program developments and activities.
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 an excellent level of experience in regulatory science and innovative 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 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 be able to coach and develop talent within the regulatory organization.
● You should have a University or higher degree in a scientific or technical discipline. Paediatric and Orphan drug 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