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Maidenhead

    Regulatory Specialist and Senior Specialist - Maidenhead, Berkshire, United Kingdom - SRG

    SRG
    SRG Maidenhead, Berkshire, United Kingdom

    6 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    SRG are currently looking for Regulatory Specialist for a Global Pharmaceutical Company who have opened new vacancies within their Regulatory team on an initial 12 Month basis to be based at their office in Maidenhead/Remote.


    The Role:
    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 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.
    § Review of and input on documents related to clinical trial submissions managed by other stakeholders.
    § Ensure approved company CTA processes are followed within agreed timelines.
    § 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.
    § Provide technical support on document preparation.
    § 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.

    Skills/Experience Require

    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
    § At least 2-years CTA experience 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.
    § Proactive verbal and written communication style at all levels.
    § 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.
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