Our cutting-edge, vaccine client is seeking a Sr. Director, Regulatory Affairs (REMOTE) to their growing team! This role will be accountable for developing regulatory strategies for their 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. Our successful candidate will have significant regulatory experience in vaccine development with a focus on Europe and the US. Responsibilities include but not limited to:
- 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.
Requirements:
- Minimum of a bachelor’s degree in a related Science Field; advanced degree in Science desirable AND 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.
- 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.
Travel:
- Location in Boston or Europe 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.