As our Regulatory Affairs Associate here in
Oxford, you will support the European Regulatory Affairs team, calling on your
documentation experience for European agencies such as CTAs, PIPs and
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. Youâ€™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 daysâ€™ 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
If you are innovative and focused on achieving success within
a collaborative environment, please visit our website www.vrtx.com to find out more information and apply.
The Science of Possibility.
Closing date for applications is 12 October 2012