Pharvaris Careers

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for the prevention and treatment of hereditary angioedema (HAE) attacks, and other bradykinin B2-receptor-mediated indications. HAE is a rare and potentially life-threatening genetic disease and people living with HAE can suffer sudden and prolonged attacks of swelling in multiple areas of the body, including the airway, which can be life-threatening.

To support our lead programs aimed at bringing new, oral options to people living with HAE, we have an opportunity for a highly driven Manager, Regulatory Operations to join and support our regulatory affairs strategy and priorities.

If you are an innovative and pragmatic Regulatory Affairs 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 Operations, you will be responsible for project management and compilation of regulatory submission deliverables ensuring submissions are of the highest quality and delivered on time. You will also format and publish electronic documents, archive and track regulatory correspondences, and manage Regulatory Information in a RIM system.

Location

We have offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area) and, at Pharvaris, we promote and enable a flexible hybrid work-environment and support our talent to be home based and work virtually. This role is preferably based in the USA, in the Greater Boston area.

Scope

Responsibilities for this role include:

• Electronically format, publish submission documents and build Regulatory Submission Deliverables and ensure quality, accuracy, and submission-readiness per regulatory agency guidance and specifications, and internal procedure
• Manage Publishing vendors who are responsible for compiling Pharvaris’ eCTD submissions to the FDA
• Archive (categorizing and classifying information) all regulatory records such as correspondences, commitments, health authority questions, and submissions pertaining to multiple regulatory applications (e.g., IND, NDA, CTA, MAA, NeeS)
• Assist with developing and maintaining standards and procedure documents (SOP, WI) for procedures related to regulatory document and submission development
• Assist with implementing and maintaining regulatory systems, and identification of regulatory submission process improvements. Develop and suggest scalable solutions and processes for business process improvements
• Assist with maintenance of Submission Document Authoring Template Library and Template development
• Provide guidance on good documentation and submission practices to project teams
• Identify and communicate regulatory system enhancement needs and technical issues

Requirements/Key Attributes:

• Bachelor’s degree, preferably in a scientific field
• 5+ years’ experience in drug development, 2+ in Regulatory Affairs
• Knowledge of regulatory drug development
• Good understanding of applicable FDA and ICH guidelines related to Regulatory Submissions and Documents
• Clear understanding of Regulatory Submission content and format requirements
• Advanced knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-ins (e.g., ISIToolBox), Regulatory Document Management Systems, eCTD Publishing, Validation and Viewing systems, and XML are required. Working knowledge of submission document authoring templates (e.g., StartingPoint) is preferred

We are looking for someone that:

• Can work independently
• Has the ability to multitask
• Is self-motivated, well organized, detail oriented, able to prioritize, and can work effectively under pressure
• Has good written and verbal communication skills
• Is comfortable in a small company environment that is fast paced, challenging and where all employees must take a hands-on approach to get results

Interested?

Please send your resume to [email protected]. We look forward to speaking to you.

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for the prevention and treatment of hereditary angioedema (HAE) attacks, and other bradykinin B2-receptor-mediated indications. HAE is a rare and potentially life-threatening genetic disease and people living with HAE can suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening.

We are expanding our global Medical Affairs team and are looking for a Scientific Publications Lead, to join our team and report to our Senior Director of Medical Affairs.  

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.

Location

We have offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area) and, at Pharvaris, we promote and enable a flexible hybrid work environment where our employees choose from where (and to some extent when) they prefer to work. Whilst this is a remote/hybrid role, you need to be based in either the U.S. (East coast), the Netherlands or Switzerland. For this role we are focusing on talent over location.

Scope

Responsibilities for this role include:

• Executing the global scientific publications strategy, ensuring alignment with the medical and company strategy
• Developing, managing and delivering the annual publications plan, including manuscripts, abstracts, congress presentations and posters
• Managing the end-to-end publications process (from development to journal submission and congress presentation)
• Managing relationships with KOLs, authors and external vendors to facilitate smooth collaboration and timely publication
• Overseeing the creation of high-quality scientific content, ensuring all publications adhere to Good Publication Practices (GPP), industry standards
• Translating complex scientific data into clear, compelling and compliant medical content for diverse audiences, including medical education materials
• Partnering cross-functionally with Medical Affairs, Patients Advocacy, Early Development, Clinical Development, and Evidence, Value and Outcomes Research to develop and align publication strategies aligned with company imperatives
• Supporting advisory boards, speaker programs, medical education activities and (scientific) symposia with key publications and medical content
• Maintaining awareness of the latest trends and advancements in the pharmaceutical industry to drive innovation and improve publication practices
• Working closely with the legal and compliance team to ensure all ethical information and publications activities meet legal and ethical standards
• Ensuring proper archiving and documentation of publication materials in compliance with company policies and regulatory requirements

Requirements/Key Attributes:

• Advanced scientific degree (PhD, PharmD, MD or MSc), preferably in life sciences or another health-related field
• Preferably 5 years+ global experience in publication management or medical communications (in a pharmaceutical/biotech environment), ideally in the field of rare disease or, more specifically, hereditary angioedema (HAE)
• Preference for candidates who have worked for emerging biopharmaceutical companies in the past, with evolving operating procedures and employee remits
• Prior leadership or cross functional team experience (managing vendors, overseeing projects, leading publications planning)
• Experience working in a highly regulated environment, preferably familiar with ICMJE, GPP, and other international standards for ensuring the quality and transparency of publications
• Proficiency using medical/scientific publication databases/resources and project software
• Proficiency in Microsoft Office (Word, PowerPoint, Excel, Outlook)

We are looking for someone that has:

• Good attention to detail with critical and analytical skills
• Excellent communications skills (verbal and written)
• Excellent project management skills
• Problem solving skills
• Results-oriented
• Strong team player with an international mindset
• Natural ability to influence and lead projects

Interested?

Please send your resume to [email protected]. We look forward to speaking to you.