ProClinical is currently seeking a Senior Manager Regulatory Operations for a leading pharmaceutical company based in London, UK. This is a contract role.
- To provide senior management and employees with optimal regulatory publishing and submission support and advice and ensure high quality submissions are made on time and on budget in line with clinical and commercial business needs.
- To manage, lead and provide oversight of internal and outsourced publishing services and administrative submissions support activities in accordance with the objectives of the company.
- To provide expertise, guidance and support on publishing requirements, related processes and use of Documentum (ADMS) system.
- Responsible for establishing common document templates, file naming and version control, to ensure compliant, submission ready and traceable document lifecycle management for development activities (CTAs), pre-submission activities (scientific advice, request for procedure number assignment, etc), submission activities (MAA modules) and post-authorisation activities.
- Responsible for managing, planning and leading all document management activities required to publish high quality regulatory and clinical submissions i.e. study reports, protocols to agreed timelines, across a range of products in various stages of development including publishing strategies and vendor oversight where outsourced submission publishing is required.
- The above includes hands on in-house publishing of individual documents e.g. clinical study reports and checking documents produced by third parties to ensure published output is of a standard which meets US/EU/EEA requirements for eCTD submission as well as in-house specifications.
- Establish IT infrastructure for compilation and submission of CTAs, CTDs and eCTDs to EMA/EU/EAA . Scope to include administrative support to compilation systems, ADMS (Documentum), publishing platforms and validator software, submission gateways (EMA eSubmission Gateway and/or Webclient/CESP/National Portals)
- Serves as the Regulatory Operations representative on cross-functional teams within the company, communicating submission timelines and project status and working closely with Functional groups to meet submission timelines and timely document deliverables for submission publishing
- Serves as the company Regulatory Operations (RO) Representative at the Global RO Subcommittee. Actively contributes to the initiatives arising from the Subcommittee and ensures that global processes are compatible with regional requirements.
Skills and Requirements:
- Knowledge and experience of Documentum and a number of publishing tools; specific experience with docuBridge and eCTD document control tools and validation software
- Common office software packages, Outlook, internet, databases
- Educated to degree level preferably in Lifesciences or a non science based degree with considerable experience in publishing eCTDs and lifecycle management
- Extensive experience in compilation and validation of electronic and paper regulatory submissions in accordance with EU/ rest of Europe/US standards
- Sound understanding of publishing software used to compile and publish eCTDs, NeES, CTAs and reports (Clinical Study Reports, Investigational Medicinal Product Dossiers etc.).
- Good understanding of EDMS systems and Docubridge with one or more of the following Publishing tools : ISI eCTD Xpress, Insight Publisher and s-cubed or equivalent.
- The ability to work with minimal oversight across a diverse range of projects.
- Ability to manage resource and time constraints to deliver regulatory submissions to agreed timelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.