Senior Global Submission Manager
il y a 2 semaines
Ready to help shape the future of healthcare? Your talent can bring our science to life
As a , we empower you to be yourself, share ideas and work collaboratively
Senior Global Submission Manager
Job purpose:
As a Senior Global Submission Manager , you will work with global submission teams and third parties to project manage complex regulatory submissions (including global marketing applications, product line extensions and supplements) from submission through to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidances and with GSK SOPs and working practices. You will as well mentor/coach Global Submission Managers.
Please note that there are two open vacancies with flexibility on the location : Belgium, United Kingdom, Italy.
In this role you will...
Be accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major complex regulatory submissions Perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines. Maintain or provide inputs into plans which drive strategic resource planning Through collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of that content, target governance board review timeframes, and credible dispatch and Health Authority approval dates for key markets Lead submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understand the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process. Provide various visuals, reports, scorecards, etc., to facilitate awareness of key milestones, closely monitor critical path activities, and ensure transparency of submission status to stakeholders. Provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets Utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated GSK systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays. Be responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities. Participate in discussions/meetings with Regulatory Authorities, as required, to develop and communicate submission strategies for applications. Fluency in English is required considered the interactions at a global scale. French, Italian or Japanese is a plusWhy you?
Master degree in a biological, healthcare or scientific discipline or extensive experience within the drug development environment Project management experience in the pharmaceutical industry or in a regulatory environment. Detailed understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Extensive knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV Global / RoW Regulatory experience Expertise with Microsoft Project and/or other project management tools Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome. Excellent written and verbal communication skills and ability to present information in a clear and concise manner Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives. Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment. Proven ability to think flexibly in order to meet constantly shifting priorities and timelines. Effectively lead multidisciplinary team meetings and drive discussions regarding submission content, timelines, resource allocation, risk management, etc. Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stake holders to ensure transparency of submission progress/status. Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams. Sense of urgency and ability to work well in high pressure / high stress situations#LI-Hybrid
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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