Director, Regulatory Affairs — Global Impact Leader (Remote)

Allucent; Bracknell; Hybrid; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Flexible working hours

Remote/hybrid depending on location

Mentoring and leadership development

Job summary

Allucent is seeking a Director of Regulatory Affairs to lead regulatory teams, shape strategy, and ensure high-quality submissions across drug, biologic, and medical device programs. You will guide HA interactions and translate complex regulations into practical plans for global clients.

You will mentor teams, oversee projects of varying complexity, and drive successful outcomes while advancing innovative therapies in healthcare.

Qualifications

• Advanced knowledge of HA regulatory guidance & regulations across drug, biologic, and device development.
• Experience with US FDA, Health Canada and/or European authorities.
• Strategic advisory and translating regulatory requirements into actionable plans.
• In-depth knowledge of CTD format and structure for regulatory submissions.

Responsibilities

• Lead regulatory teams and projects across diverse client programs.
• Provide strategic regulatory advice and compliant submissions guidance.
• Review and author regulatory and scientific documents.
• Serve as Subject Matter Expert, Technical Lead, or Consulting Lead on projects.
• Mentor and develop regulatory staff and teams.

Skills

Strategic leadership

Regulatory strategy

HA interactions

CTD knowledge

Regulatory project oversight

Education

B.Sc./M.Sc./Ph.D. in a scientific field

Job description

Allucent is seeking a Director of Regulatory Affairs to lead regulatory teams, shape strategy, and ensure high-quality submissions across drug, biologic, and medical device programs. You will guide HA interactions and translate complex regulations into practical plans for global clients.

You will mentor teams, oversee projects of varying complexity, and drive successful outcomes while advancing innovative therapies in healthcare.