- Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Contribute to effective forecasting and management of project-specific resources utilizing flexible resourcing, and global load-sharing as a normal business practice.
- Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
- Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Delivering project-specific Pfizer electronic and paper regulatory submissions. Including coordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at the local level.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
Qualification & Experience:
- Proven experience managing or delivering through others in a team environment