European Regulatory Affairs Programme Manager

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Title
European Regulatory Affairs Programme Manager
Job type
Permanent
Location
Welwyn, UK / Basel, Switzerland
Web site
Description

Roche are at the forefront of developing ground-breaking new medicines and consistently push the boundaries of conventional thinking and embrace innovation across our business.  With a strong pipeline, we are looking for people to support global teams to develop and gain approvals for medicines in Europe and Rest of World countries. 

 

The Opportunity

 

We currently have an opportunity for an EU Regulatory Programme Manager to join our global team working primarily on our Ophthalmology and/or Infectious Diseases portfolio. The role will be based in Welwyn Garden City in the UK preferably or in Basel.

Working independently, as well as within a regulatory sub-team, you will participate in and represent the regulatory function on cross-functional teams in early and/or late stage projects, giving strategic regulatory input to those teams through a drug’s development and lifecycle. 

You will support or lead interactions with Health Authorities in the EU and other key countries.  That will include the preparation of registration documents for centralized MAA/variations, core dossiers for CTAs and briefing packages for Scientific Advice and Qualification Advice. You may also support registration activities in key countries outside of the EU.

As the primary interface with Affiliate Regulatory Affairs, you will ensure Affiliates are informed of project developments and activities and you will work with your global team to provide responses to Regulatory questions from Affiliates.

We support our staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.

 

Who are we looking for?

 

We are looking for a highly motivated and committed individual who has broad regulatory knowledge and the experience and ability to manage complex issues with meticulous efficiency.

As a Regulatory Affairs professional, you should bring a very good level of experience in regulatory science and clinical drug development, e.g. sound knowledge of EU legislation, guidelines and procedures, successful management of regulatory submissions and procedures, direct interaction with Health Authorities and strategic regulatory input in drug discovery and development, especially clinical aspects.

We are looking for strong leadership competencies, so you should be an agile strategic thinker with exceptional communication skills at all levels and the ability to work effectively both within a team environment and independently.  You should be able to influence teams and functions in defining global development strategies.

You should have a University or higher degree in a scientific or technical discipline. Ideally you will have experience within the Ophthalmology and/or Infectious Diseases therapeutic areas. Paediatric development experience would be a plus.

You will be fluent in both written and spoken English, with an awareness of working globally.

 

Ready to apply? 

Closing date for applications: February 21st

Roche is an equal opportunity employer.

Organisation
Roche
Deadline
21/02/2019