非公開
This is what you will do:
The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for our commercial and investigational products. The duty includes collaborating with the global CMC/RA team, managing the team member of Japanese CMC regulatory, selecting and managing external contractors and proposing an appropriate budget plan for the successful CMC regulatory activities.
You will be responsible for:
- Independently manage and accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including compliance of clinical and commercial products.
- Plan, coordinate, and manage the development, preparation and submission of the CMC sections of Alexion’s registration dossiers and supplements (partial change application and minor change notification) for commercial products in Japan.
- Develop proactive regulatory strategies for Japan CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams.
- Effectively build and lead project teams for CMC submissions.
- Create and maintain detailed project plans to ensure clarity of deliverables and timing through the use of project management tools and principles.
- Constantly monitor and evaluate GRA-CMC team's progress towards meeting milestones and timelines, through active communication and review of pertinent information.
- Identify and monitor critical path activities and develop contingency plans.
- Publish clear and concise meeting agendas, minutes, and action items. Track action items through to completion.
- Provide feedback to management of project progress / scope changes / risks and impact to timelines.
- Drive timely decisions, and facilitate active communication and information flow between team members, senior management and impacted sites / functional areas.
- Research and provide interpretive analyses of regulatory guidance documents, regulations, or directives that impact CMC for Japan. Operates independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
- Prepare responses to Japanese Health Authorities’ questions and comments; prepare briefing packages as assigned. Interfaces directly with Japanese Health Authorities in order to discuss and define regulatory applications. May act as CMC representative in formal meetings and teleconferences with Japanese Health Authorities.
高い開発力を持った成長中グローバル希少疾患メーカーです