Closing Date: 07 Dec 16
Type: Full Time
Salary (£): On Application
> We currently have an opportunity for a Regulatory Programme Manager to join our global team working within our Immunology/Inflammation, Infectious Disease, Neuroscience and/or Ophtalmology Therapeutic Area. The role will be based in Welwyn Garden City or in Basel. ...
We currently have an opportunity for a Regulatory Programme Manager to join our global team working within our Immunology/Inflammation, Infectious Disease, Neuroscience and/or Ophtalmology Therapeutic Area. The role will be based in Welwyn Garden City 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 ensure Affiliates are informed of project developments and activities and you will work with your headquarters colleagues 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 you areYou’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
We are looking for a highly motivated and committed individual with strong leadership competencies, so you should be a 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 demonstrate the capability to negotiate and influence stakeholders for a successful output and partner with matrix teams in defining global development strategies.
As a Regulatory Affairs professional, you should bring a 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. You will have a broad regulatory knowledge and the experience and ability to manage complex issues with meticulous efficiency.
You should have a University or higher degree in a scientific or technical discipline. Ideally you will have experience within the Immunology/Inflammation, Infectious Disease, Neuroscience and/or Ophtalmology Therapeutic Area.
You will be fluent in both written and spoken English, with an awareness of working globally.
Please ensure you have the approval of your line manager before applying for this vacancy.
Closing date for applications is 12th December. Good luck!
Who we areOur UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
|Tel:||+44 1707 36 6000|
|Fax:||+44 1707 33 8297|
|Website:||Visit Our Web Site|
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