Senior Manager, Regulatory Affairs
Remote – United Kingdom
A growing clinical-stage biotech is looking to appoint a Senior Manager, Regulatory Affairs to support global Oncology development programs and European Regulatory activities.
This role will have a strong focus on supporting and executing European/regional Regulatory strategy, partnering closely with cross-functional teams to drive submissions and support key development milestones.
Key Responsibilities:
• Support European and regional Regulatory strategy across development programs
• Act as a key Regulatory representative within cross-functional project teams
• Lead and coordinate regulatory submissions including CTAs, INDs, amendments and marketing applications
• Coordinate contributors across CTD Modules 1–5 and manage submission timelines
• Ensure submissions are high quality, compliant and eCTD-ready
• Support Health Authority responses and post-approval lifecycle activities
Requirements:
• Degree in Life Sciences or related discipline
• 6+ years’ Regulatory Affairs within biotech or pharma
• Experience supporting clinical trial and marketing applications
• Late-stage development and Oncology experience desirable
• Strong understanding of CTD/eCTD submissions
• Excellent organisational skills and attention to detail
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