HUB Submissions Manager
A well-known international pharmaceutical company with sites around the globe is looking to hire a HUB Submissions Manager. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- Leading and managing logistical and technical aspects associated with submission management, ensuring development and delivery of X-Regional, Regional and/or National regulatory dossiers (initial application, lifecycle updates, compliance and maintenance) to Worldwide Health Authorities.
- Executing, through the use of standards and tools, designated operational tasks (e.g. submission planning, document receipt, translation management, technical build and submittal to HA or applicable country office.
- Ensuring that the company delivers on all regulatory submission milestones and maintains compliance with applicable regulatory obligations.
- Working to tight, business-critical deadlines within a highly regulated environment.
- 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.
- Engaging with submission leaders, business suppliers and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
- Delivering project specific electronic and paper regulatory submissions, including co-ordination and execution of publishing solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and subsequent archival.
- Maintaining a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and publishing and translation requirements as required.
- Ongoing liaison 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 publishing, including the evaluation of current processes.
- Leading/participating in global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Helping to interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at a 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 the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Participating in the definition and implementation of national and regional process efficiencies for submission publishing and project learning sessions.
- Operating as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues Technical Skill Requirements
Skills and Requirements:
- Proven experience managing or delivering through others in a matrix environment.
- Demonstrated ability to work within a demanding environment with a strong focus on quality and timelines.
- Working experience or proven ability to learn an array of technical tools.
- Demonstrate leadership and team skills.
- Knowledge and experience of the drug development process, regulatory filing guidelines and electronic submissions is preferred but not essential Prior Experience and Education Preferred.
- Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
- Demonstration of experience working in a challenging customer service environment.
- Highly proficient project manager/communicator.
- Familiarity with pharmaceutical organizational structures/systems and experience building full paper and electronic submissions is preferred, but not essential.
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 0203 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.