Job Description
General Summary:
The Senior Director, Regulatory Strategy International, is a regulatory leader with expert technical and tactical experience in regulatory strategy who will be responsible for overseeing the development and implementation of advanced global regulatory strategies across international markets (those outside North America, which includes the European Affiliates (EU, UK, and CH) and Rest of World (ROW)) . This includes (1) development programs in emerging disease areas, (2) additional development of registered Vertex medicines, and/or (3) support of Vertex marketed products. The incumbent is responsible for team management and will play a major role in shaping cohesive regulatory strategy across assigned programs, ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.
Key Duties and Responsibilities:
Leads the development of International regulatory strategy for international markets, which may include multiple and/or complex projects at different stages of development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including regulatory submission documents and Health Authority communications
Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy, as required
Addresses complex issues, providing advanced regulatory solutions and guidance to cross- functional teams and align communication to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices.
Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy.
Effectively working with cross-department teams (e.g., submission and launch teams, within Regulatory, etc.) leaders to achieve corporate business and department goals and objectives
Leads continuous improvement efforts on existing department processes and strategies - for example aligning on new & more efficient ways of working, mapping processes, creating new business documents (e.g., new SOPs)
Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams
As a people manager within the International GRA organization, may have financial accountabilities and human resource responsibilities for assigned staff
Member of the International Regulatory Affairs Leadership Team
Exhibit ownership and accountability for all project and internal assignments
Exemplify Vertex’s core values in fulfilling these job duties
Knowledge and Skills:
Recent direct experience of regulatory submissions and maintenance of approvals across multiple therapeutic areas and product modalities. Must include leading direct interactions with a variety of stakeholders including consultants, partners, EMA, and competent national authorities.
Extensive experience of defining and executing International regulatory strategy, including leading policy discussions with a focus on Europe and other International markets.
Ability to apply regulatory knowledge with a broad global and cross-functional mindset essential
Demonstrates excellent communication skills with ability to impact and influence the decisions of a…