The opportunity
The Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly visible role will work in a matrixed cross functional project team, interacting with contributors and leadership within the R&D environment to align optimal submission plans with demanding timelines in full compliance with external and internal requirements.
This role will lead multidisciplinary Product Submission Teams where they will manage regulatory document planning, establish dossier timelines, identify and expedite critical path deliverables, and orchestrate hand-offs to Regulatory Operations or the local International Market RA teams. The individual will also conduct scenario and contingency planning to avoid time delays. The ideal candidate will develop efficient and innovative approaches to successfully deliver on-time and high-quality dossiers.
This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, and the ability to rapidly learn associated Teva systems and planning software. The position requires regulatory knowledge of content requirements of and experience with major applications, including global NCE marketing applications, product line extensions and supplements.
This is primarily an individual contributor role, though it may include managing 1 or more direct reports at a later stage.
How you’ll spend your day
Responsible to manage Product Submission Team and dossier timelines.
Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management.
Regularly reports to management on progress against objectives and plans.
Guides project teams on Teva submission-related processes and content and format requirements for key markets.
In close collaboration with cross functional team members, creates and maintains regulatory project plans that capture detailed dossier content, key activities and timelines required to deliver that content to achieve aggressive submission timelines for highly prioritized major applications.
Leads submission planning discussions, keeping all stakeholders informed and engaged of upcoming deliverables, aligned on roles and responsibilities, and aware of the interdependencies between R&D activities and submission components. Identify, communicate, and mitigate any issues, risks, or adaptations needed as challenges arise.
In collaboration with regulatory lead and project leader, conduct scenario planning when multiple regulatory strategies are being considered.
Communicate key milestones, critical path activities, and ensure transparency of regulatory plan status to stakeholders.
Understands and advises others on global Regulatory Authority regulations and guidance associated with required submission components, which differ across regions and Regulatory Authorities.
Provides training and mentorship to regulatory staff.
