My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Submission Coordinator on...
SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team and are looking to recruit a Regulatory Affairs Coordinator - on an initial 12 Month contract to be based at their offices in Berkshire.
- Operational support to Clinical Trial Submissions team, leads for submission preparation and processing of initial CTA applications, amendments, end of trial notifications etc.
- Preparation of documentation associated with new initial CTAs and CTA maintenance activities such as substantial amendments, end of trial notifications etc.
- Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB and Protocols.
- Ensure approved company CTA processes are followed.
- Ensure all relevant databases, activity trackers and questions database are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
- Provide technical support on document preparation e.g. Excel spreadsheets, Power point presentations.
- Organizing legalization and signature of documents in line with global affiliate requirements.
- Undertake all necessary training in order to achieve compliance with internal/external processes.
- Provide operational/administrative support for the Clinical Trials Regulatory Group.
- Support SOP reviews and updates when required.
- Comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company.
- Life Sciences Degree qualified.
- 1 year Regulatory Affairs or R&D experience preferable.
- Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
- Proactive verbal and written communication style at all levels.
- Shows high level of initiative and ability to work independently
- Has excellent communication/presentation skills, written and verbal; fluency in English.
- Strong proven personal development and motivational skills.
- Strong interpersonal, organisational and team working skills.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srg.co.uk or +441753 589673