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SRG are currently looking for Regulatory Specialist for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Maidenhead.
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.
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.
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 Clinical Trial Strategy & Submissions Team as required.
Comply with the company's policies and procedures.
Preferred: Relevant advanced degree in life sciences is preferred
Required: Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
At least 2-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.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: firstname.lastname@example.org or +441615077288