Regulatory Affairs Specialist
Up to £30 an hour, 37.5 hours a week, flexi-time
A fantastic opportunity has opened up in the Regulatory Affairs team of a global pharmaceutical manufacturer.
My client are a global innovation company with an extensive customer base across the EU and US. They now have an exciting position within their Regulatory affairs on a contract basis for 12 months at their new offices.
About the Job
Reporting directly to the Regulatory manager, you will support the Drug Delivery Systems Business in the commercialisation of a range of pharmaceutical products for customers on a global basis.
This will include pharmaceutical products across the EU and US, providing regulatory advice on product change and maintenance issues and coordinate regulatory documentation (CTDs and CEPs).
You will also have responsibility for estimation and monitoring of regulatory resource requirements.
Working directly with Product Assurance Technical Teams and customers you will also ensure generation of approvable Global regulatory data packages to support change.
In terms of experience, you will have EU pharmaceutical regulatory experience, ideally with CMC variations experience and have worked with MRP and DCP.
You will also demonstrate:
- Proven project planning skills
- Strong written and verbal communication skills
- Highly developed interpersonal and team skills with experience of dealing with external customers
- Strategic thinker who can deliver regulatory solutions
- Easily adaptive to change and new circumstances
- Able to handle multiple and complex tasks and be comfortable getting involved in detailed regulatory work as well as understand the bigger picture
- Capable of understanding the business needs and priorities and translating these into appropriate regulatory actions
- Bachelors degree in Science
Apply today! Or for more information contact Sophia at Consult Search & Selection
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