Graduate Trainee Program in Drug Regulatory Affairs (2 years)

Job description

  Job facts

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
·  Support and participate in 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).
To broaden your experience across the development value chain you will also have the opportunity to go for up to a six month rotation period in another Pharma Development function.

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .

Roche is an equal opportunity employer.

Desired profile

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. Where a job title is not considered the final definition of who you are, but the starting point.

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.
Moreover you are/have:

·  Been exposed to the Pharmaceutical Industry (ideally Regulatory Affairs) during an internship
·  Strong team-work is one of your strengths
·  Able to work under pressure and to deadlines
·  Expected to demonstrate flexibility, good coordination and strong communication skills as we are working in a very dynamic environment
·  Someone who learns quickly and you have very good written and spoken English skills
The preferred start date is October 2017.Applications need to include a CV and a cover letter.
·