Description
Associate Director Regulatory Affairs - Oncology - Global Pharmaceutical - Up to £90,000Associate Director Regulatory Affairs - Oncology - Global Pharmaceutical - Up to £90,000
There is an opportunity to work for a leading global pharmaceutical company in theUKwho are currently looking for an Associate Director to join their Oncology team.
You will be joining an excellent team of experts and will be given the opportunity to work alongside the Director on future Oncology projects. The position is specific to the regulatory support of Oncology products and therefore you will need to have regulatory oncology experience and already be working at a senior level within Regulatory Affairs.
Key Skills/Experience
- BS degree or equivalent in science; advanced degree preferred
- 10 years pharmaceutical/biological drug development experience
- Minimum 8 years direct regulatory affairs experience
- Proven European regulatory submissions capability, ideally in both pre-submission and post authorisation activities; this should include experience on oncology projects.
- Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities.
- Detailed knowledge of EU regulations and guidelines on drug development and submissions both pre and post approval including oncology guidelines.
- Knowledge of eCTD.
- Experience working with CROs and/or contractors.
- Some previous management experience preferred
This is an excellent opportunity for someone who is looking to take the next step in their career. The company offer full support, definite future career progression and their reputation is second to none.
If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact Amanda Edwards on or please email a.edwards(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com