Global Marketed Products Program Manager or EU Marketed Products Program Manager

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

As EU Marketed Products Program Manager you provide EU regulatory guidance and critical issue management of assigned products governed by EU registration procedures (Centralised or Mutual Recognition). You serve as key interface with EMEA. In addition, you may a fulfill global role.As Global Marketed Products Program Manager you serve as key interface with regulatory affiliates for national registration procedures globally (EU/US/ROW) on product(s) as assigned.  You provide global regulatory guidance and critical issue management of assigned products. In addition, you may fulfill a role of EU Marketed Products Program Manager.

• You provide global and/or local regulatory strategic direction for assigned product(s) and ensures alignment with Global Marketed Products Program Manager, Global Therapeutic Area Leader and/or Regional management as appropriate.
• You ensure Global Therapeutic Area Leader and/or Regional management are fully informed of key regulatory activities and critical issues.
• You ensure regulatory strategic options, assessments and risks are communicated to product teams in collaboration with Global Marketed Products Program Manager and/or Global Therapeutic Area Leader as appropriate.
• You give regulatory guidance on critical issue management, guidelines, procedures, appropriate labeling, and health authority interactions.
• You demonstrate leadership on the team and within the function to accomplish business objectives.
• You coordinate activities with PDR resources to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.

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'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 substantial experience in International Regulatory Affairs, a good knowledge of regulatory processes, especially in the EU. For the global role you should have at least vast experience in Global Drug Regulatory Affairs. Working knowledge of core processes in discovery, development, manufacturing and marketing is also required. Good communication, demonstrated leadership skills, 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