Global Regulatory Submissions Lead

Freyr Solutions; United Kingdom; On-site; GBP 85,000 - 120,000; Full time

Job summary

Freyr Solutions in the United Kingdom seeks a senior Regulatory Submission Manager to oversee global regulatory submissions and lead cross-functional teams across product life cycles. You will coordinate timelines, provide specialist regulatory guidance, and drive process improvements to accelerate speed-to-filing.

You will represent the team on regulatory submissions, mentor colleagues, and ensure compliance with US, EU, and other major health authority requirements while advancing submission

Qualifications

• BA/BS with 8+ years of submission management or regulatory operations experience.
• Experience in global regulatory submissions (US/EU/ACE).
• Ability to coach and guide teams.
• Strong knowledge of health authority requirements.
• Proven track record across multiple regions.

Responsibilities

• Plan and oversee global/regional submission content plans.
• Lead review and planning for multiple products.
• Coordinate timelines and stakeholder activities.
• Represent RSM in cross-functional teams.
• Develop process improvements and standards.
• Coach and train less experienced colleagues.
• Ensure compliance with regulatory requirements.

Skills

Regulatory submission management

Regulatory affairs expertise

Project coordination

Cross-functional leadership

Regulatory intelligence

Education

Bachelor's degree in life sciences

Tools

Veeva

Job description

Freyr Solutions in the United Kingdom seeks a senior Regulatory Submission Manager to oversee global regulatory submissions and lead cross-functional teams across product life cycles. You will coordinate timelines, provide specialist regulatory guidance, and drive process improvements to accelerate speed-to-filing.

You will represent the team on regulatory submissions, mentor colleagues, and ensure compliance with US, EU, and other major health authority requirements while advancing submission