Senior Director, Regulatory Affairs

Job content

Job Summary

The Senior Director of Regulatory Affairs must have a broad understanding of the global regulatory requirements including EU and other international markets and be able to prepare and manage global submissions. The Senior Director must be able to develop, communicate and implement regulatory strategy. The Senior Director develops objectives, schedules, and performance metrics and ensures that all requirements are met and is required to manage direct report regulatory team members.

Job Responsibilities

• Goal set, manage, train, motivate and direct regulatory staff reporting to the Senior Director.
• Provide regulatory advice and guidance to direct reports and other development team members and be actively involved in preparation, review and approval of regulatory submissions.
• Day to day management of EU/International Regulatory group.
• Represent Regulatory Affairs on global project teams, subteams and in joint alliances as required. Representation may be ad hoc or permanent depending on the stage of the project.
• Direct all aspects of regulatory support and strategy for EU and international for the global project team on the designated product(s).
• Ensure the project team regulatory objectives and timelines are validated and supported by well defined and agreed regulatory deliverables
• Interface with management to ensure consistency of regulatory strategy and alignment with corporate goals.
• Lead, facilitate and coordinate and manage regulator meetings for the assigned projects.
• Lead, facilitate and manage within function regulatory team meetings such as Global Regulatory Team meetings and Regulatory Submission teams
• Provide expertise in the interpretation of regulations and guidance relating to product development.
• Implement and maintain a Regulatory Intelligence system
• Deputize for the SVP Regulatory Affairs
• Lead and represent regulatory affairs during Health Authority Inspections (e.g. PV)
• Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
• Coordinate with the US based Regulatory Affairs group to ensure alignment on global regulatory strategy and submissions.
• Coordinate and manage consultants and contractors as required.
• Budget responsibility
• Represent RA function on the Cambridge Management Team

Qualifications

• Broad understanding of drug development and oncology preferred.
• Competency in regulatory requirements is essential. Global experience a plus.
• Excellent verbal and written skills.
• Flexible mindset and ability to multitask.

Education and Experience

• Minimum of BSc in a relevant scientific discipline, advanced degree
• Strong scientific background
• Experience of EU centralized procedure and in communicating with EMA in written and verbal formats
• 10+ years of regulatory affairs experience and at least 15 years pharmaceutical industry experience.
• Experience of contributing and serving on project teams.

Working Conditions

Office-based, variable travel, up to approximately 10%

• No recruitment agency applications will be accepted at this time.