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Job Details

European Regulatory Affairs Programme Manager

Company: Roche
Location: Welwyn Basel Headquarter
Reference: 201807-113047
Closing Date: 17 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Who are we?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. ...

Requirements:

Who are we?

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 experienced Regulatory Programme Manager to join our global team working primarily on our Immunology/Rheumatology and/or Gastro-Intestinal 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 MAA/variations and core dossiers for CTAs.  You shall coordinate and lead regulatory submissions and manage registration procedures for new MAAs and/or variations in the EU, ensuring successful registration and acceptable labelling. 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 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 Immunology/Rheumatology and/or Gastro-Intestinal 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.

Interested? 

When completing your application, please ensure you attach an up to date CV.

Closing date for applications is Tuesday 31st July 2018.

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

Apply for this job: European Regulatory Affairs Programme Manager

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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