EMEA Regulatory Affairs Manager — Remote

Worldwide Clinical Trials; England; On-site; GBP 65,000 - 90,000; Full time

Job summary

Worldwide seeks a senior Regulatory Affairs professional to lead global submissions across EMEA, APAC and LATAM, ensuring compliance with evolving regulations. The role involves coordinating ethics submissions, supporting business development, and mentoring junior staff in a fast-paced, multinational environment.

The candidate will provide expert regulatory advice, prepare technical documents like IMPDs and IBs, and liaise with sponsors, project managers, CRAs and Medical & Scientific Affairs

Qualifications

• Bachelor-level or higher in life sciences or related field.
• 8+ years of experience in clinical research or regulatory affairs.
• Strong English communication and cross-cultural collaboration.

Responsibilities

• Review study budgets and costing related to contract negotiations and participate in bid defenses.
• Coordinate and manage regulatory and ethics submissions across EMEA, APAC and LATAM with approvals.
• Provide expert regulatory advice and contribute to regulatory project work; communicate submission status to stakeholders.
• Train, coach, and mentor junior staff; may line-manage team members.

Skills

Leadership

Planning & scheduling

Written and verbal communication

Cross-cultural communication

Relationship-building

Multitasking under deadline pressure

Education

Four-year college curriculum in medical/biological/physical health

Two-year college curriculum or equivalent (life science)

Job description

Worldwide seeks a senior Regulatory Affairs professional to lead global submissions across EMEA, APAC and LATAM, ensuring compliance with evolving regulations. The role involves coordinating ethics submissions, supporting business development, and mentoring junior staff in a fast-paced, multinational environment.

The candidate will provide expert regulatory advice, prepare technical documents like IMPDs and IBs, and liaise with sponsors, project managers, CRAs and Medical & Scientific Affairs