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We are working with this growing CRO to fill the role of Regulatory Affairs Manager to be based in their Slough office.
Job summary:
oProvides regulatory affairs advice and support for all Company projects.
oAssists with the management of regulatory affairs and technical writing services within the organisation.
oProvides regulatory advice, support and documentation relating to the Company's business activities worldwide.
oDevises and assists in delivery of regulatory affairs training across Company departments.
oLine manages assigned staff.
oActs as a mentor and source of expertise to Regulatory staff.
oSupports business development activities.
oAssists the Associate Director, Regulatory Affairs to develop business opportunities for the regulatory affairs department.
oEnsures clinical trials are conducted such that subjects’ rights, safety and well being are protected and that the clinical trial data are reliable.
Job Duties and Responsibilities:
oParticipates in all departmental project related activities.
oProduces global clinical trial applications, clinical study reports, publications and summary documents.
oProduces expert reports, investigator brochures, protocols and supporting regulatory documentation.
oReviews and QC’s regulatory documents.
oAssists the Associate Director Regulatory Affairs and regulatory affairs staff to manage projects in line with budgets and agreed timelines to achieve client satisfaction.
oSources appropriate data, information and documentation from clients and/or their nominees to fulfil regulatory requirements.
oSupports regulatory affairs management in ensuring departmental awareness and compliance of current local, national, regional and harmonised guidance and requirements for the format, content, and control of all types of regulatory and ethics procedures and submissions.
o In conjunction with regulatory affairs Management, creates and maintains regulatory templates for all types of submissions.
o In conjunction with regulatory affairs Management, creates and maintains specific project tracking systems incorporating all relevant information.
o Acts as a contact for and liaises with clients, project managers and other members of project teams to obtain relevant information to fulfil regulatory requirements.
oMaintains a superior awareness and familiarity with the current global regulatory affairs environment.
oMaintains specific project tracking systems incorporating all relevant information.
oLiaises with project managers and other members of project teams to fulfil regulatory requirements.
oGenerates and reviews reports of regulatory data using appropriate systems.
oPrioritises personal workload in line with agreed project plans.
oUses appropriate IT and software tools to ensure the correct format and presentation of documents.
oAssembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
oFollows internal SOPs, specifically those relating to Technical Writing and Regulatory
oAffairs.
oDevelops and writes SOP’s.
oAchieves appropriate quality standards in all documentation within the timelines dictated by project plans.
oParticipates in business development activities
oEnsures annual leave and sick leave are approved and taken in accordance with company guidelines.
oReviews and authorises expense reports in accordance with company and project guidelines.
oMonitors workload of assigned staff.
oMotivates staff and encourage them to be efficient and proactive.
oIs involved in objective setting and annual appraisals of staff.
To apply for this role you will meet the following brief:
oGraduate, postgraduate or equivalent, ideally in a scientific or healthcare discipline.
oPrevious experience of clinical trial regulatory affairs either in CRO or pharmaceutical industry.
oExtensive experience of global clinical trials.
oLine management or supervisory experience.
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
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