Global Regulatory Leader / EU Partner

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site.

The Position

Within a team of Regulatory Professionals in the Program Management Group, based either at headquarters in Basle, Switzerland, or our large R&D site in Welwyn, UK, you will be responsible for  providing  strategic advice and proactive regulatory input to the internal functions for the management of products under development, and managing the EU (or global) registration procedures. You will represent Regulatory Affairs at relevant products teams meetings. You will be leading the interactions with the regulatory agencies. In addition, you will be responsible for preparing regulatory submissions in collaboration with other functions and plans relating to the regulatory submissions.

• You represent the function on cross-functional teams (Product Teams/Lifecycle Team).
• You manage the registration procedures globally or in EU (National, Centralised or Mutual Recognition) and ROW.
• You give specific guidance to the team/functions on regulatory issues such as legislation, guidelines, procedures etc.
• You give regulatory input to ensure acceptable labelling in various markets.
• You take the lead in the interaction with alternatively regulatory agencies during product lifecycle management
• You prepare regulatory submissions in collaboration with the other disciplines.
• You coordinate core dossiers for CTAs.
• You prepare integrated plans relating to the regulatory submissions or specific functional projects.
• You answer questions from authorities and subsidiaries.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

You should have a University degree, preferably in a scientific / technical discipline.You should also have several years experience in International Regulatory Affairs, a good knowledge of regulatory processes, especially in the EU. For the Global Regulatory Leader role you should have at least a vast experience in Global Drug Regulatory Affairs. Working knowledge of core processes in discovery, development, manufacturing and marketing is also required. Good communication, interpersonal skills and good knowledge of English and the ability to work in a team-based environment is essential.

 
The next step is yours. To apply today, click on the "Apply online" button below.

Roche is an Equal Opportunity Employer