Graduate Trainee Program in Drug Regulatory Affairs (2 years)

Job description

·  Job facts

At Roche, we believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future.

We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world.

As a Graduate Trainee within the Pharma Development Drug Regulatory Affairs Group in Basel, you will gain hands-on experience with increasing responsibility on the work of Regulatory Affairs professionals who are responsible for providing the Regulatory input and leadership from drug development through to lifecycle maintenance of the product. Activities include initiating the “First in Human” studies, all the way to the end of product commercialization.

The trainee program is a two-year program that offers you the opportunity to get hands on experience working in the regulatory affairs department of one of the largest Pharmaceutical companies in the world. Your assignments may include both activities in early development and marketed products with your own discrete tasks and responsibilities.

You will be supporting products, working closely with the Global Regulatory Leader and Regulatory Manager responsible for EU and other global regions. Your tasks may cover activities across the whole development value chain from clinical trial applications through to license applications and maintenance.

Some examples of activities you will be involved with may be (and are not limited to):

·  Prepare regulatory submissions in collaboration with other disciplines in the department
·  Participate in and support the development and implementation of the regulatory strategies
·  Acquire and maintain an overview of relevant regulatory requirements
·  Assist in the planning and preparation of regulatory documents
·  As part of your assignment you may be required to spend some time in another regulatory function (for e.g. Regulatory Intelligence)

We are keen to discover talents who are passionate about learning and show great curiosity in discovering new things. At the Roche Headquarter site in Basel/Kaiseraugst, employees from over 90 countries are doing now what our patients need next. We contribute our share towards achieving our mission and to make our vision of personalized healthcare happen. We offer you a multicultural workplace in a modern environment, which at the same time requires you to be open-minded and adaptable.

Who we are

At Roche, 94,000 people across 100 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.

Roche is an equal opportunity employer.

Desired profile

Who you are

·  You have recently or are about to receive your Master or PhD degree in life or pharmaceutical sciences within the last 12 months, preferably with focus in regulatory affairs
·  You have preferably been exposed to the Pharmaceutical Industry (ideally Regulatory Affairs) during an internship
·  Teamwork: work effectively as a team member, being proactive and transparent with other team member
·  Time Management: exercising conscious control over the amount of time spent on specific activities, especially to increase efficiency or productivity, managing efficiently multiple tasks in parallel, being able to focus on the priorities
·  As we are working in a very dynamic environment, you are expected to demonstrate flexibility, good coordination and strong communication skills
·  Strategic and Innovative Thinking: apply regulatory and scientific knowledge to determine solutions and solve complex problems. Develop clear, effective and creative regulatory strategies to support goals
·  Fluency in written and spoken English

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want work in a passionate team, make your mark & improve lives, apply now.

The preferred start date is October 2019.

Applications need to include a CV and a cover letter that also includes answers to these 3 questions:

·  Why do you want to do a traineeship in Drug Regulatory Affairs?
·  What relevant skills and experience will you bring to this position?
·  What challenges do you see in the field of Drug Regulatory Affairs?

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

If you still have questions, then please check our FAQs and videos on careers.roche.ch/faq.

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