Director, Global Regulatory Strategy – Pharma

Eisai Pharma AG; Hatfield; Hybrid; GBP 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid working

Car/Car Allowance

Electric charging points

Discretionary Bonus

Free onsite parking

Subsidised onsite restaurant and café

Learning and development opportunities

Retail discounts

Well-being & mental health programmes

Multi-faith prayer room

Job summary

Eisai is seeking a Director, Global Regulatory Strategy to lead the submission of Neurology trial applications and product registrations. You will guide project teams on regulatory agency interactions to expedite approvals, and act as regulatory liaison throughout the product lifecycle.

You will ensure trial designs meet regulatory requirements and support collaboration with partners for rapid, compliant market access across oncology and neurology, with hybrid working options at Eisai's EKC EU

Qualifications

• Extensive industry experience in Regulatory Affairs within biotech/biopharmaceuticals.
• Proven track record interfacing with global regulatory agencies (EMA, etc.).
• Experience with Clinical Trial Applications submission and ongoing maintenance.
• Paediatric Investigation Plan experience preferred but not required.
• Strong understanding of regulations governing pharmaceutical development and registration.

Responsibilities

• Direct the submission of Neurology clinical trial applications, product registration dossiers, supplements, and amendments.
• Provide strategic direction to project teams on regulatory agency interactions to expedite approvals.
• Serve as regulatory liaison to project teams throughout the product lifecycle.
• Ensure clinical trial designs meet regulatory requirements and aim for rapid approval of new drugs, biologics and devices.
• Support collaboration development with external partners.

Skills

Regulatory Affairs

Global regulatory liaison

Clinical trial submissions

Paediatric ITP experience

Regulatory guidelines

Job description

Eisai is seeking a Director, Global Regulatory Strategy to lead the submission of Neurology trial applications and product registrations. You will guide project teams on regulatory agency interactions to expedite approvals, and act as regulatory liaison throughout the product lifecycle.

You will ensure trial designs meet regulatory requirements and support collaboration with partners for rapid, compliant market access across oncology and neurology, with hybrid working options at Eisai's EKC EU