Senior Manager, Regulatory Project Manager - Job ID: 1820
Ascendis Pharma
Regulatory Project Manager
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory submissions across the Ascendis pipeline.
As a part of the Global Regulatory Affairs team, you will be responsible for contributing to the vision, strategy, and infrastructure of Ascendis Global Regulatory Affairs. This role can be based in either our Palo Alto, CA or Princeton, New Jersey office, and will report directly to the Head of Global Regulatory Operations.
Key Responsibilities
- Collaborate with Global Regulatory Affairs Leadership in establishing and managing timelines for key project milestones, adhering to processes and documentation, and communicating with cross-functional teams or key stakeholders within and across regions to ensure the delivery of business objectives.
- Participate in Regulatory filing teams, providing project management expertise in the end-to-end planning, coordination, and execution of assigned Regulatory submissions project deliverables.
- Monitor submission deliverables as required to support investigational (IND/CTA) and marketing applications (BLA/NDS/MAA), and global clinical trials as required.
- Work with key stakeholders for major submissions, identifying risks, opportunities and mitigation strategies, ensuring successful and on-time project execution.
- Provide project management support to regulatory agency interactions and the preparations for the interaction.
- Strive for efficiency by ensuring consistent approaches and development of best practices.
Vacancy posted 5 days ago
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