An internationally renowned pharmaceutical organisation is seeking to hire a Hub Submissions Manager for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
The Hub Submission Manager will be accountable for the operational management of regional and/or national regulatory dossiers to designated Health Authorities (HAs) and will focus on their allocated region/countries, along with the additional responsibility supporting other locations through utilization of global tools. On behalf of Worldwide Safety & Regulatory (WSR), they will lead and manage logistical and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers - initial application and subsequent lifecycle updates (compliance and maintenance).
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 delivery 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.
- Defining, investigating, and implementing regional, national, 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.
- Effectively forecasting and managing project specific resources, utilising 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:
- S./B.Sc is in Pharmacy, Life Sciences, Business, or Information Technology (desirable); equivalent relevant professional experience will be considered.
- Multi-lingual skills desirable.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
- Demonstrated coordination of activities in a highly regulated environment.
- Proven aptitude in project management and logistics.
- Demonstration of 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.
- Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
- Formal training in technical tools.
- Knowledge of drug development process.
- 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 with computer skills, such as 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 Numhom 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.
#LI-116605466_NS1
#RegulatoryAffairs
.png)
