Regulatory Director

Job Description

Job Summary:

• The Global Regulatory Lead is responsible for the global regulatory strategy and execution.

Duties and Responsibilities:

• Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s).
• Lead the regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions.
  Drive the regulatory submission process for all types of submissions through to approval.
• This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality.
• Partner with Regulatory Project Management and Submission Management.
• Ensure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes.
• This may be done by an experienced Regional Regulatory Lead with strong support from the GRL.
• Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.
• Matrix leadership role of GRST – ensure project resource requirements are suitably managed.
• Participate in cross-functional and GRA initiatives

Required Skills:

• Advanced degree and at least 6 years of relevant experience.
• A minimum of 3 years of recent oncology experience.
• Experienced strategist with a record of successful HA interactions with FDA or EMA.
• Demonstrated strong matrix leader.
• Excellent spoken and written English.