Regulatory Operations Manager
Astellas Pharma
- Nederland
- Vast
- Voltijds
- Manage the planning, preparation, delivery, and archiving of published submissions to regulatory agencies around the globe, commonly focusing on Europe, the Middle East, and Africa.
- Ensure adherence to relevant submission standards, regulatory pathways, and regulatory strategies to facilitate efficiency of agency review.
- Support submission activities for affiliates and business partners around the globe, commonly focusing on specific geographies.
- Execute processes to promote electronic document and submission quality control.
- Maintain strong working relationships with Regulatory Affairs, members of Project Management, and publishing vendors to set submission timelines and content plans.
- Ability to work independently with minimal direction and within project teams to attain group goals.
- Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
- Strong ability to communicate effectively in writing and verbally in English.
- Strong affinity with technology.
- Ability to multi-task across multiple projects and deliverables.
- Knowledge of different regulatory procedures and submissions in EU.
- Fluent in written and spoken business English.
- Experience with managing IT systems or providing business operational support.
- Strong knowledge of document management, submission publishing and/or registration management systems.
- Basic understanding of data warehousing and reporting/analytics platforms or concepts.
- Bachelor's Degree or equivalent.
- This is a permanent, full-time position.
- This position is based in the Netherlands (Leiden).
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.