Overview
In this role you will lead the development and execution of global regulatory strategies for international markets, shaping regulatory input across multiple programs. You will collaborate with regional teams to align clinical and commercial strategy with regulatory objectives. You will address complex regulatory issues, provide guidance to cross-functional partners, and drive momentum on submissions and approvals. This position offers the opportunity to influence policy discussions, stay ahead of regulatory changes, and contribute to Vertex’s mission to deliver patient-focused therapies. You will work within a hybrid setup and lead a high-performing regulatory function dedicated to ambitious
Responsibilities
- Develop and oversee international regulatory strategy for multiple projects across development stages and into post-marketing.
- Represent GRA on core development and cross-functional teams, aligning regulatory input with clinical and commercial plans.
- Provide advanced regulatory guidance to senior management and cross-functional groups.
- Plan, manage, and prioritize project timelines and resource allocation to meet key milestones.
- Engage with external regulators and participate in industry/regulatory meetings to influence the regulatory environment.
- Collaborate across departments to achieve business and department goals; lead process improvements and new SOPs.
- Lead GRA functional teams, including coaching, performance feedback, and talent development.
- Possibly assume people management and budget responsibilities within International GRA.
- Contribute to the International Regulatory Affairs Leadership Team and uphold Vertex values.
Key requirements
- Direct experience with regulatory submissions and maintenance across multiple therapeutic areas and modalities, including EMA interactions.
- Extensive background in defining and executing international regulatory strategy with emphasis on Europe and international markets.
- Strong ability to apply regulatory knowledge in a global, cross-functional context.
- Excellent written and verbal communication; capable of influencing decisions and presenting regulatory plans and submissions.
- Regulatory leadership in a matrix, cross-functional team environment.
- Deep technical expertise in regulatory science and knowledge of global/regional/local requirements for human medicines.
- Delegation and people development capabilities; fluent written and spoken English.
- strong communication
- influence and negotiation
- leadership and mentorship
- regulatory strategy development
- regulatory submissions and lifecycle management
- EMA and international regulatory affairs
Senior Director, Intl Regulatory Affairs Geo-Expansion in London employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer, offering a dynamic work environment at their Milton Park R&D facility in Abingdon, where innovation thrives. Employees benefit from a strong focus on professional development, with access to training resources that foster growth in the pharmaceutical industry. The inclusive culture encourages collaboration across disciplines, making it a rewarding place for those passionate about making a meaningful impact through science.
