Description
Regulatory Affairs Manager - Orphan Drugs - Home working - Up to £65,000Regulatory Affairs Manager - Orphan Drugs - Home working - Up to £65,000
We are currently working with an exciting new and up coming company on an executive search to find a regulatory affairs manager to join the team. This company is a privately held start up specialist pharmaceutical company dedicated to improving the lives of children with rare diseases. Established in late 2011 this client is developing two late stage drugs to treat a number of Orphan diseases. The company has reached key milestones using a virtual model of bringing in expertise in relevant areas. However, it is now moving towards the next phase of its life and is looking to bring in a regulatory affairs manager. This is an exciting and stretching role for the right minded individual to add value in an organisation at a very early level.
Key Skills/Experience
- Life science degree
- 5+ years regulatory affairs experience
- Experience working for an SME pharmaceutical company
- Pre approval experience essential
- CMC experience
- Experience preparing Maa's
- NDA experience desirable
- Experience working with orphan drugs desirable
- European regulatory experience (FDA regulatory experience desirable)
- Regulatory strategy experience desirable
This opportunity is an excellent opportunity for someone who is interested in bringing new drugs to market. This would suit someone who is entrepreneurial, driven, willing to take risks and adaptable. The right candidate would need to be flexible, confident, be able to use their own initiative and give good advice.
You ill be working in a relaxed and flexible environment with colleagues that are friendly, open minded and very easy to work with!
If this sounds like something of interest to you and you would like to find out more, please contact Amanda Edwards on a.edwards(a)realstaffing.com or call ASAP
To find out more about Real please visit www.realstaffing.com