- Role: Regulatory Associate – CTA
- Contract: 12-month rolling
- Office- Maidenhead (hybrid) – 3 days on site
SRG are partnered with a global biopharmaceutical company with focus and capabilities to address some of the world’s greatest health challenges. Our client combines advanced science, expertise and passion to solve serious health issues and have a remarkable impact on people’s lives.
JOB SUMMARY:
The Regulatory Associate is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.
KEY DUTIES AND RESPONSIBILITIES:
- 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.
- SME on all aspects of EU CTR submissions including platform and complex trials, guiding cross functional teams through the process and providing training and education on the processes. Define strategy for CTR transitions and initial submission alongside other key stakeholders. Modify processes and strategy based on lessons learned.
- Lead CTA specific scientific advice procedures, including advising study teams and management of the different options and leading strategies on when to utilize
- 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.
- Good understanding of CTR process and requirements.
- 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 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 as 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
- This position reports to the Associate Director, CTS
Education
- Required: Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
- Preferred: Relevant advanced degree in life sciences is preferred
Experience
- At least 5-6 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
- Experience working effectively across cultures and in a complex 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 global databases.
- Proactive verbal and written communication style at all levels.
- Solution driven style.
- 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.
- Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
- Has critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
- Strong Project Management skills, able to manage multiple activities in line with
- business priorities and study time goals
- Understands business needs and impact of regulatory issues on these.