Graduate Programme Regulatory Affairs

Job description

·  Job facts

Graduate Trainee Positions in Regulatory Program Management, Regulatory Documentation and Regulatory Labelling (2-year Program)

We are currently seeking four exceptional Graduates to join our successful 2-year programme based in our award winning offices in Welwyn Garden City, Hertfordshire, UK.

There are four Graduate Trainee opportunities within the Product Development Regulatory Group: two in Program Management, one in Regulatory Documentation and one in Regulatory Labelling. You'll be considered for all three areas, but if you have a preference please indicate in your cover letter which area and why.

For all roles, the Graduate Programme is a 2-year journey that offers you the opportunity to get hands on work experience including assignments to your own discrete tasks and responsibilities. You will gain insight into the work of Regulatory professionals who are responsible for providing the Regulatory input and leadership throughout the lifecycle of the product, from initial first-in-man studies, through marketing authorisation submission and approval, and all the way to the point at which the product lifecycle comes to an end.

To broaden your experience across the pharmaceutical development value chain, you will also have the opportunity to go for a 6-month rotation in another Product Development or UK Business function.

Regulatory Programme Management

You will be providing support to Global Regulatory Leaders and Regulatory Managers responsible for the EU and Rest of the World area by working on various regulatory activities across the whole development value chain from clinical trial applications through to license applications and lifecycle maintenance.

Regulatory Documentation

You will be working with global drug development teams to bring novel pharmaceutical products to patients worldwide through planning and preparing a broad range of regulatory and scientific documents, developing your medical writing skills and knowledge of global regulations. You will have the opportunity to work on many document types, within different therapy areas and at all stages of product development.

Regulatory Labelling

You will be working with global drug development and commercial teams developing and writing the Core Data Sheet (CDS) which is the company position for Roche Pharmaceutical products. You will also be responsible for developing and writing the EU and US local labels for Roche Pharmaceutical products. The role involves working in partnership with Regulatory Programme Management and leading cross functional experts located globally, ensuring key scientific data and core safety information is provided to all patients in our product labels.

Qualifications

You have at least a BSc in life or pharmaceutical sciences, or a similar scientific qualification.

Some relevant work experience (up to 1 year) or training would be an advantage. However, if you already work within a Regulatory environment this would not be the right role for you.

Teamwork is one of your strengths and you are able to work under pressure and to deadlines. Working in a dynamic environment, you are expected to demonstrate flexibility, good organisational skills and strong written and verbal communication. Furthermore you are someone who learns quickly and who has very good English language skills.

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

Application Process:

Stage 1:

-CV & Cover Letter

Please ensure you include a CV and a cover letter with your application. As part of your cover letter, Roche is keen to understand your motivation in applying for this position. You should, therefore, provide responses to the following questions:

• What is your primary motivation for applying for this role at Roche?

• What skills and experience will you bring to the role?

Your cover letter should not exceed one page.

-Video Interview

Once a HR review has been completed you may be invited to complete a video Interview to support your application.

Stage 2:

Assessment Centre

If successful at the Video, CV and Cover Letter screen, we will invite successful candidates to attend an

all-day assessment centre on 27/03/2020. Please note that we would be unable to accommodate candidates who would not be available to attend this date.

Closing date for applications: 21/02/2020

·  Who we are

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.