Director, Head of International Regulatory Policy & Intelligence

Vertex

London, UK

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The Head of Regulatory Policy & Intelligence is a leadership position that will drive the development and execution of the Vertex International Regulatory Policy agenda by providing expertise/input along with building relationships with key external stakeholders. He/She will identify regulatory policy issues/trends/changes occurring in the regulated environment that have the potential to impact our products and facilitate/support the adaptation of product strategies accordingly in order to enhance asset probability of success. He/She will actively engage externally to shape the international policy environment in line with Vertex priorities. He/She will be responsible for partnering with key internal functions (i.e. Development, Government Affairs, Commercial etc) and/or relevant subject matter experts to set policy agenda and engage in direct regulatory advocacy activities. The critical initial focus of this role is the EU regulatory arena.

Additional responsibilities may include:

  • Provide thought leadership in International Regulatory policy and maintain/develop mutually beneficial relationships with key leadership at Health Authorities and other external stakeholders.
  • Drive Vertex agenda through targeted participation on external committees and coalitions (i.e. major trade associations, public private partnerships, academia etc) along with attendance at EMA workshops.
  • Identify and respond to EU regulatory/legislative policy issues that impact research, development and lifecycle management.
  • Support international regulatory affairs and product development with focused regulatory strategy derived from deep knowledge/understanding of regulatory external/competitive environment.
  • Develop cross-functional communication and implementation plans to convey complex regulatory policy issues with impact to the business. Ensure external analysis is internalized to facilitate product strategy; track progress.
  • Due to the complexity and sensitivity of these needs, the incumbent must be able to demonstrate highly evolved strategic and influencing skills in interacting at all levels.
  • Ability to work effectively and effortlessly as an individual contributor in a highly collaborative and team oriented environment are essential components in this role.
  • Member of the European Regulatory leadership team

Minimum Qualifications

  • Industry experience
  • Recent Regulatory authority experience preferably EMA/CHMP or CAT
  • Must have extensive experience of at least 1 of the following: Orphan Drug Regulation, Pediatric Regulation, ATMP Regulation
  • Experience of being involved in guidance authoring
  • Higher education (Master/PhD) preferred.
  • Demonstrable history of successfully serving in a leadership role Recognized expert in regulations, guidelines and precedents related to pharmaceutical development for small molecules or biologics.
  • Skilled communicator and presenter.
  • Deep understanding of the political environment and culture within the EMA/CHMP and CAT and the ability to identify key players to be engaged.
  • Significant experience interacting with senior EMA members

Company Information

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.

Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com.


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