Regulatory Affairs Manager - New Drug Development

South West England  ‐ Onsite
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Keywords

Description

Regulatory Affairs Project Manager - Respiratory Drug Development - SME Pharma - Up to £65,000.

Regulatory Affairs Project Manager - Respiratory Drug Development - SME Pharma - Up to £65,000.

I am currently working with an SME drug development company based in the south west region of the UK who specialise in developing drugs for rare respiratory diseases. They are a large independent company and currently looking to expand their regulatory affairs team. Due to a recent acquisition, the work load has increased and they are now looking for an experienced senior project manager to join the team. You will need to have strong pre approval regulatory affairs experience and this needs to be on a European scale.

Key skills/Requirements

- 5 - 10 years regulatory affairs experience

- Strong pre approval experience

- Phase II and III experience

- CTA experience

- Previous experience compiling and submitting an MAA

- Experience of leading your own projects (no line management experience needed)

- DCP experience a must

- Strong European experience

Desirables:

- CMC experience

- Respiratory experience

- MRP experience

- Paediatric experience

This is a great opportunity for someone to mould into their own. The company's environment is very relaxed and sociable and they offer great support with career progression. They like to bring people into the team that are hard working, show initiative and can be their own boss and who can also demonstrate great personable skills with it.

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
Start date
05/2014
From
Real Staffing
Published at
03.06.2014
Project ID:
717653
Contract type
Permanent
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