Italy - Siena, UK - London - Brentford, Belgium-WavrePosted Date:
Jun 9 2021
As a Regulatory Global Submission Manager, you will work with global submission teams and third parties to project manage regulatory submissions (primarily global NCE/NBE marketing applications and product line extensions) from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner. The job holder will manage submission teams, lead discussion of deliverables and timings, facilitate scenario planning and perform impact analysis. He/she will 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 and proactively focus on critical path acceleration, efficient hand-offs, and reduction in "rework" to avoid costly time delays, while at the same time ensuring all necessary quality reviews and approvals are achieved, allowing GSK to continue producing applications to the highest quality standard.
Key Responsibilities include, but are not limited to:
Accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major submissions.
Acts as subject matter expert to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
Through collaboration with contributing functional lines, creates and maintains 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.
To ensure GSK's competitiveness in drug development, work with teams to identify ways to optimize and accelerate bringing products in our late-stage pipeline to market, focusing on key activities and processes from last subject last visit (LSLV) to submission and approval.
Leads submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands 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.
Performs scenario planning when multiple regulatory strategies are being considered.
Provides various visuals, reports, scorecards, etc, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
Works closely with data generating groups to monitor progress and ensure team is on-track to delivery according to plan. When potential issues and delays are identified, works to expeditiously find solutions in order to keep the team progressing toward the target submission timeframe.
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.
Facilitate post-submission after action reviews (AARs) to identify key learnings and best practices which are then used to refine and improve GSK submission processes.
Education - preferred degree in a biological, health care, or life science discipline
Experienced in the pharmaceutical industry
Project management experience in the pharmaceutical industry, preferred in regulatory environment
Detailed understanding of the pharmaceutical drug and vaccine development environment, and R&D processes and objectives
Extensive knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV
Global / EMAP Regulatory experience
Proficiency 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
Proven effectiveness leading multidisciplinary teams and driving discussion regarding submission content, timelines, resource allocation, risk management, etc.
Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives.
Ability to proactively identify and mitigate risks and potential bottlenecks and effectively interact with stakeholders 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
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
At GSK we offer:
Important and interesting job in one of the leading global healthcare companies.
An opportunity to play a key role in bringing new medicines and vaccines to patients.
A position that liaises with various functional areas and culminates years of work into a marketing application that is submitted around the world.
Possibility to work with engaged and enthusiastic people from various locations.
Training on the newest project portfolio management software solutions and content management platforms.
Possibilities of development within the role and company's structure.
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
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.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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