Senior Director, Regulatory Affairs

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.

We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:
The Sr Director, Regulatory Affairs is accountable for developing regulatory strategies for norovirus vaccine candidates with an emphasis on European requirements for early and late stage assets. This person will be a key regulatory leader who partners with internal and external stakeholders to achieve successful regulatory filings and approvals in Europe, US and international.

The successful candidate will have significant regulatory experience in vaccine development with a focus on Europe and the US.

Responsibilities:

• Implement the regulatory strategies for early and late stage assets and actively contribute to the associated clinical development plans.
• Provide critical regulatory input to cross functional internal teams, external CROs and consultants in the planning, organizing, and submission of regulatory dossiers to EMA, European NRAs and other global regulatory agencies.
• Translate current regulatory requirements into practical submission strategies in Europe and worldwide.
• Liaise with CROs to prepare clinical content of submissions in Latin America and Asia.
• Track and evaluate changes to regulatory requirements and guidelines as they impact development of company assets.

Education, Experience & Skills:

• Minimum of a bachelor’s degree in a related Science Field; advanced degree in Science desirable
• A minimum of 7 years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility.  Experience with vaccines preferred.
• A working knowledge of US, EU and international regulatory and GxP standards relevant to the development and approval of new vaccines.
• Direct experience leading and preparing for regulatory agency meetings
• Extensive knowledge of clinical trial designs and global reporting requirements
• Experience developing the clinical and labeling content and format for original and supplemental license applications.
• The ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (regulatory authorities, vendors, investigators, and other stakeholders).
• Ability to work in a fast paced/flat/dynamic small company environment
• Excellent influencing and negotiating experience and capabilities in a matrix environment
• Able to handle multiple projects and exercise good judgment in prioritizing tasks.
• Proficient with Microsoft Office and Veeva Vault applications, Adobe and document management templates.

• Location in Boston preferred; remote or hybrid options will be considered.
• Willingness to travel (20-25%) to various meetings or client sites, including overnight trips and international travel.

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.