Date Posted: Wednesday, 21st of July 2010
Salary: Up to £90000
Start Date: ASAP
Telephone: 01438743047
Location: Buckinghamshire
Consultant Name: Jonathan Hart Smith
Sector: Pharmaceutical
Director of Regulatory Affairs
As the Director of Regulatory Affairs you will provide European regulatory guidance and strategy to your regulatory colleagues and global project teams leading to sound scientific development programs and successfulregistration for new biological compounds and new indications.
You will liaise, negotiate and partner with European Regulatory Agencies. Represent the company during Agency (National/EMA) interactions; able to schedule and lead meetings with Agencies and prepare company personnel for Agency interactions. Determine the content for the Quality related section of regulatory submissions as well as evaluate submissions for accuracy. You will also prepare regulatory responses to requests from health authorities and meet aggressive deadlines to ensure that regulatory Agencies receive timely and scientifically robust submissions, shortening the review process and leading to successful approval of biological products for the company’s growththereby accomplishing corporate goals.
What makes this job different?
Our Client is truly a leader in its field. You can expect a smaller company feel providing you with room to grow and influence others but with the financial backing and security of an established corporate organisation. If you want to not only make a difference to the end users and patients but also help shape the way that the European Regulatory department function then this is an ideal opportunity. It will give you strategic and operational input and responsibilities.
For more information or to apply, please get in touch with Jonathan on 01438743047 or email: jhartsmith@ckclinical.co.uk
