SRG are currently recruiting for a Regulatory Affairs Consultant to work on a 12-month full-time contract. During the COVID-19 pandemic this role will be remote, client location is in Berkshire.
The Regulatory Consultant is responsible for providing UK regulatory expertise for Clinical Trials across multiple therapeutic areas for assigned asset(s). Predominately, the Regulatory Consultant will be focusing on the preparation and submission of initial clinical trial applications (CTA) and CTA maintenance activities (substantial amendments, urgent safety measures, end of trial notifications etc.). The main priority will be to ensure the compliant regulatory maintenance of the assigned asset(s) across the UK. However, the right individual will also have the opportunity to be involved in new upcoming and innovative UK regulatory submissions (pre-MAA and post-MAA).
- Manage a portfolio of CTAs across multiple and far-reaching therapeutic areas, 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. Support internal and external inspection readiness activities when applicable
- Lead regulatory agency interactions and the review process
- 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
- Comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
- Opportunity to support development and pre-MAA regulatory strategy within the UK affiliate (in post-Brexit regulatory environment)
Competencies and Capabilities
- Solid communication skills, especially in writing. Good capability of delivering key communications with clarity, impact and passion whilst working with a 'patient first' mentality
- Capable of identifying issues in advance and seeking necessary support to resolve. Creative ability to strategize solutions to regulatory obstacles, whilst balancing expectations of regulatory agencies
- Ability to make informed and calculated decisions with limited information
- Displays a continual focus on improving performance and excellence. Not afraid to challenge and questions ways of working to seek improvements to established processes. Required: Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
- At least 5 years' Regulatory Affairs experience, preferably in global clinical trial submissions to regulatory agencies.
- Post-approval Lifecycle maintenance experience is advantageous
- Experience working effectively across cultures and in a matrix environment
- Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and regulatory databases.
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