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Job Details

Principal Regulatory Programme Manager

Company: Roche
Location: Welwyn
Reference: 201810-125708
Closing Date: 12 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Principal Regulatory Programme ManagerRoche 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 highly motivated people to support global teams to develop and gain approvals for medicines in Europe and Rest of World countries. ...

Requirements:

Principal Regulatory Programme Manager

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 highly motivated 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 a Principal Regulatory Programme Manager to join our global team working primarily on our Ophthalmology portfolio. In this role you will preferably be joining our colleagues located in Basel or Welwyn.

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

You lead or support interactions with Health Authorities in the European Union and other key countries. That includes the preparation of registration documents for MAA/variations and core dossiers for CTAs. You 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 link with Affiliate Regulatory Affairs, you ensure Affiliates are informed of project developments and activities and you work with your headquarters colleagues to provide responses to Regulatory questions from Affiliates.

What else are we offering? We are dedicated to 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 seeking a committed individual who has broad regulatory knowledge and the experience and ability to lead multiple complex projects/issues with meticulous efficiency.

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

We'd like you to bring demonstrated leadership competencies; you are 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 are able to influence teams and functions in defining global development strategies, and skilled at persuasion, networking and conflict resolution/negotiation.

You are fluent in both written and spoken English, with an awareness of our global working environment.

You hold a University or higher degree in a scientific or technical discipline. Ideally you will have extensive experience within the ophthalmology therapeutic area. Experience with medical products incorporating medical device components would be a plus.

Interested?

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

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

Apply for this job: Principal Regulatory 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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