Aktuelle Jobs im Zusammenhang mit Biomedical Research Submission Manager - Basel, Basel-Stadt - Novartis Farmacéutica
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Biomedical Research Submission Manager
vor 1 Woche
The Biomedical Research Submission Management, Associate Director is responsible for leading cross-functional submission sub-teams to project manage regulatory submissions. This includes preparing applications and dossiers in a timely manner and in compliance with regulations.
About the Role- Manage local submission management teams.
- Prepare BR submission components including NDA and MAA dossiers.
- Develop strategic submission plans and execute them.
- Provide data visuals and monitor critical path activities.
- Managerial responsibility for local submission management team.
- Manage preparation of BR submission components including NDA and MAA dossiers.
- Lead submission planning discussions and develop comprehensive strategic submission plan.
- Provide various data visuals to facilitate awareness of key milestones and closely monitor critical path activities.
- Undergraduate degree in scientific discipline or life science background or equivalent work experience.
- 5-10 years' experience working in regulated life science environment.
- Project management experience in pharmaceutical industry or regulatory environment.
- Expert knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV preferred.
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
