Senior Global Submission Manager

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique GSK Temps plein

Site Name:
Belgium, Italy, UK - London - Brentford

Posted Date:
Jun 5 2024

Senior Global Submission Manager:

Job purpose:
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 indepth 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.
  • Fluency in English is required considered the interactions at a global scale. French, Italian or Japanese is a plus

Why you?

  • Qualifications & Skills: _
  • 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 preIND 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
  • Preferred Qualifications & Skills: _
  • 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.
  • 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 crossfunctional teams.
  • Sense of urgency and ability to work well in high pressure / high stress situations


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,

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