- Entry level
- No Education
- Salary to negotiate
- Welwyn Garden City
Regulatory Programme Manager
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.
We currently have an opportunity for an EU Regulatory Programme 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 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.
Closing Date: - Friday 24th May 2019
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.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.