Regulatory Affairs Associate
This job has now expired
As our latest Regulatory Affairs Associate here in Oxford, you will call on all your documentation experience for European agencies such as CTAs, PIPs and variations PSURs. You will be an excellent addition to a high calibre team.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Massachussetts, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey.
You will provide regulatory support and expertise on assigned programmes, and take responsibility for specific pieces of moderately complex projects. You will also review scientific documents intended for submission to regulatory authorities
Helping plan and prepare submissions to regulatory authorities, you will have sufficient freedom to solve problems and will independently decide on the best and most appropriate methods and procedures on new assignments. We will look to you to apply your knowledge of regulatory requirements to the review of scientific documentation intended for submission to regulatory authorities. In addition, you will analyse new regulations and guidelines and makes process improvement recommendations.
It’s a role which will see your credibility come to the fore as you prepares and delivers effective presentations for department meetings, while you may also represent the Regulatory Affairs department on assigned project sub-teams and/or task forces.
Together with an M.Sc., B.Sc. or equivalent degree and relevant work experience, you will have experience in the preparation and/or submission of documentation for European agencies such as CTAs, PIPs, variations PSURs. You’ll demonstrate effective communication skills, especially in peer-directed presentations, and be a sound project manager. You will be capable of exercising good judgment within defined procedures and practices in order to determine viable solutions, and confident dealing with a variety of colleagues.
Advanced knowledge and understanding of applicable regulations and fluent written and spoken English are essential, while a second European language would be an advantage.
In return, you can look forward to an impressive benefits package that includes 28 days’ holiday, employee stock purchase plan and group stakeholder pension. As you would expect, we are highly health-aware, so you will also be eligible for private medical, dental and optical insurance as well as life insurance. Plus you can take advantage of our work place nursery and gym membership.
If you are innovative and focused on achieving success within a collaborative environment, please click on the "apply now" button.
The Science of Possibility.
Closing date for applications is 12 October 2012.