Description
Regulatory Affairs Manager - Leading Global Generics Company - EU experience - Up to £60,000Regulatory Affairs Manager - Leading Global Generics Company - EU experience - Up to £60,000
We are currently working with a leading global generics company who focus on a mix of manufacturing, research and development and documentation services whilst continuing enduring partnerships. They are currently looking for an experienced regulatory affairs manager to join their team ASAP. You will be required to be experienced within regulatory affairs, ideally in a generics company, have team management abilities and the ideal candidate will be able to understand quality assurance as well as regulatory affairs.
Due to recent developments, they have taken on a number of high profile projects and are looking for an experienced Regulatory Affairs Manager to work on behalf of one of the leading pharmaceutical companies. This role will have the flexibility of working from home and paying up to £65,000.
Key Skills/Experience
- Experience working for a CRO
- A manufacturing background
- Team management experience desirable
- Quality Assurance experience desirable
- European Regulatory Affairs desirable
- To ensure that all work carried out is in compliance with the required standards conforming to cGMP, GDP, SOPs, regulatory guidelines and H & S and Environmental guidelines.
- To review and approve change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
- Review, trending and assistance in managing of deviation reduction in conjunction with relevant departments
- Defining operating methodologies in packaging and ensure that all products produced conforms to the approved specification
- Yields are being monitored versus goals & timely corrective actions are being taken.
- Ensure training requirements are identified and the necessary training provided.
This opportunity would ideally suit someone who is looking to take the next step in their career. It is a fun and exciting environment with the opportunity for you to grow and develop the team and play a key part in the company development
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