Our client a Global Pharmaceutical Company have opened a new vacancy within their Regulatory team and are looking to recruit a Regulatory CTS Specialist on a 12 month contract to be based at their office in Berkshire.
To be responsible for providing global regulatory expertise for Clinical Trials and be the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.
- Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
- Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
- Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
- Ensure approved company CTA processes are followed within agreed timelines.
- Monitor key project milestones (actual vs. planned activities and timelines), and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures and support inspection readiness activities when applicable
- Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
- Ensure all relevant databases and activity trackers 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.
- Undertake all necessary training in order to achieve compliance with internal/external processes
- Provide operational support for the CTS Team
- Comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
- Life Sciences Degree qualified.
- At least 1 year Regulatory Affairs experience, preferably in global clinical trial submissions to regulatory agencies.
- 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.
- Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
- Strong Project Management skills, able to manage multiple activities in line with business priorities and study time goals and understands business needs and impact of regulatory issues on these.
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@srgtalent.com or +441753 589673
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