2 Year Trainee - Clinical Trial Regulatory Management

Job description

·  Job facts

At Roche, we believe it is urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives. We are brave in both decision and action; we believe that good business means a better world.

As a Graduate Trainee within the Pharma Development Drug Regulatory Affairs (PDR) 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.

Clinical Trial Regulatory Management (CTRM) is part of PDR Operations and is responsible for leading clinical trial submission activities to health authorities. CTRM collaborates with cross-functional stakeholders to define the global submission strategy and leads implementation in the EEA and key international countries.

·  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 colleagues on the Regulatory Affairs Functional Team (RAFT). Your tasks will cover activities related to clinical trials. Some examples of activities you will be involved with may be (and are not limited to):
·  Participate in and support the development and implementation of regulatory strategies for clinical trials
·  Prepare regulatory clinical trial submissions in collaboration with functional and cross functional stakeholders (e.g. Global Regulatory Lead, EU Regulatory Manager, International Regulatory Manager, Technical Regulatory, Clinical Operations, affiliates)
·  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)

Who we are

At Roche, 98,000 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
·  Strong team-work is one of your strengths
·  You are able to work under pressure and to deadlines
·  As we are working in a very dynamic environment, you are expected to demonstrate flexibility, good coordination and strong communication skills
·  Furthermore you are someone who learns quickly and you have very good written and spoken English

The preferred start date is July 2020

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

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique springboard to many other opportunities at Roche.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Roche is an equal opportunity employer.
Vocational & Development Programs, Vocational & Development Programs > Development Program

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