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Regulatory Affairs Manager - Boston, United States - Pharvaris
Description
Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have real impact on people's lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you.
We are now looking for a highly driven Manager, Regulatory Affairs to join and help implement our RA strategy and priorities. If you are an innovative and pragmatic RA professional - inspired by building effective solutions and passionate about balancing pragmatism with high quality, this could be the role for you
As a Manager, Regulatory Affairs, you will be responsible for contributing to global regulatory affairs projects for two late-stage development products in the rare disease space and with the opportunity to also collaborate on some early-stage development programs. You will help plan and prepare complex regulatory submission documents, primarily for US regulatory filings. You will support management in implementing departmental strategies and policies.
Location
This role is preferably based in the USA, preferably in the Greater Boston area. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.
Responsibilities
• Track and coordinate Regulatory activities
• Assist in the development, execution and maintenance of submission content plans, and provide status updates to designated stakeholders as requested
• Support maintenance and organization of regulatory documentation, regulatory filings, and communications archiving
• Assist in Regulatory-specific cross-functional program/study team projects to support clinical trials and registration activities as needed
• Maintain awareness of evolving Regulatory requirements, trends, and developments including regulatory competitive intelligence
Profile:
• Bachelor's degree, preferably in a scientific field
• 5+ years' experience in drug development, 2+ in Regulatory Affairs
• Knowledge of regulatory drug development
• Excellent verbal and written communication and presentation skills (English)
• Strong team player and ability to work across functions (matrix regulatory team)
• Comfortable in a small company environment that is fast paced, challenging and where all employees must take on a hands-on approach to get results
• Ability to multi-task and manage workload independently with excellent attention to detail
• Strong Microsoft Office skills. Fluency in English.
• Excited and driven by science and the vision to improve disease management and patient care
