Description
Senior Regulatory Affairs AssociateLondon Area
£40,000 - Competitive + Package.
This is a brilliant opportunity for regulatory candidates who are passionate about the life science industry and are looking to join a global CRO. This role will allow you to be commercially driven and it will allow you to gain the upmost experience within regulatory. If you have continued success and are looking for a role in the London area please read below.
To qualify for this role you will have to tick the following boxes:
- Produce Global Clinical Trial Applications
- Review QC's and Regulatory documents
- Liaises with project managers and other members of project teams to fulfil regulatory requirements.
- Follows internal SOPs, specifically those relating to Technical Writing and Regulatory Affairs.
- Develops and writes SOP's.
- 3 or more years Regulatory Affairs experience in clinical research, pharmaceutical or biotechnology company
- Current knowledge of ICH GCP, national requirements and clinical trial directive.
- Awareness of global regulatory and pharmacovigilance environments
- Extensive experience of global clinical trials (to competent authority and Ethics Committees)
- Line management or supervisory experience
- Excellent communication skills, written, aural and oral
- Excellent organisation and time management skills
This company are an international CRO serving clients around the world. If you are business minded individual this may appeal to you. They operate with more than 300 people based in the UK site.
To hear more please contact Latifah on alternatively feel free to email Latifah on L.khan at realstaffing.com