Director, Global Regulatory Strategy — Neurology Trials

LGBT Jobs; Hatfield; Hybrid; GBP 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid working

Car allowance

EV charging points

Discretionary Bonus

Free onsite parking

Onsite restaurant & coffee shop

Learning & development

Well-being programs

Prayer room

Job summary

Eisai seeks a Director, Global Regulatory Strategy to lead the submission of Neurology clinical trial applications and product registration dossiers, guiding regulatory strategy across the product lifecycle.

Based at Eisai's EU Headquarters EKC with hybrid working, the role requires extensive interaction with global agencies to accelerate approvals and ensure compliance across indications and devices.

Qualifications

• Extensive experience in direct Regulatory Affairs within biotech/biopharma.
• Proven track record interfacing with global regulatory agencies (EMA).
• Experience with Clinical Trial Applications, submissions and maintenance.
• Pediatric Investigation Plan experience is advantageous but not required.
• Strong understanding of regulations governing pharmaceutical development and registration.

Responsibilities

• Direct submission of Neurology clinical trial applications and regulatory dossiers.
• Provide strategic direction to project teams on interactions with agencies to expedite approvals.
• Serve as regulatory liaison to project teams throughout the product lifecycle.
• Ensure trial designs meet regulatory requirements and timely approvals for drugs and devices.
• Advise on development strategies and collaborate with partners on regulatory matters.

Skills

Regulatory Affairs

Global regulatory agencies

Clinical Trial Applications

Pediatric Investigation Plan

Regulatory guidelines

Job description

Eisai seeks a Director, Global Regulatory Strategy to lead the submission of Neurology clinical trial applications and product registration dossiers, guiding regulatory strategy across the product lifecycle.

Based at Eisai's EU Headquarters EKC with hybrid working, the role requires extensive interaction with global agencies to accelerate approvals and ensure compliance across indications and devices.