Proclinical is advertising a vacancy for a Hub Submissions Manager position with one of the most prestigious pharmaceutical companies in the world. This internationally recognised organisation specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. This is a brilliant opportunity to work alongside a historic and innovative company in their office in Surrey.
The Hub Submission Manager will be accountable for the operational management of regional and/or national regulatory dossiers to designated Health Authorities (Has). Based within WSR Submission Management, this role sits within a team working to tight, business-critical deadlines within a highly regulated environment. Their primary focus will be on their allocated region/countries, though they will have the additional responsibility of supporting other locations through the utilisation of global tools. Given the scope of international work, critical features of this role include successfully interfacing with multiple cultures, recognising and exploiting opportunities to use scale, cloning, and repurposing dossiers for worldwide markets where feasible.
Job Responsibilities:
- Driving submission coordination activities for assigned products and/or regulatory procedures as appropriate.
- Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
- Delivering project specific company electronic and paper regulatory submissions, including co-ordinating and executing solutions that meet unique requirements of each submission and national market, managing product deliveries to regulatory agencies, and ensuring subsequent archival.
- Liaising with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements, and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Actively participating in the definition, investigation, and implementation of national, regional, and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
- Completing assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Interpreting regulatory guidelines to produce business requirements and ensuring that those requirements are implemented where appropriate at local level.
- Contributing to effective forecasting and management of project specific resources utilizing flexible resourcing and global load sharing as normal business practice.
- Adhering to the appropriate use of technical tools through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Operating as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.
- Escalating, informing, and resolving any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
- Promoting the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
Skills and Requirements:
- B.S./B.Sc is in Pharmacy, Life Sciences, Business, or Information Technology; equivalent relevant professional experience will be considered.
- Demonstrated coordination of activities in a highly regulated environment.
- Proven aptitude in project management and logistics.
- Demonstrable experience working in a challenging customer service environment.
- Proven experience managing or delivering through others in a team environment.
- Relevant experience in electronic submissions build within the Pharmaceutical Industry.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
- A thorough understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
- A thorough knowledge of drug development process.
- Formal training in technical tools.
- Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.
- Multi-lingual skills desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
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 contact Numhok Sudsok at +44 203 871 8093 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.
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