EMEA Regulatory Affairs Manager (Remote)

Worldwide Clinical Trials; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Job summary

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs leader to guide submissions across EMEA, APAC and LATAM. You will coordinate regulatory and ethics submissions, mentor junior staff, and provide strategic regulatory guidance to drive successful clinical programs.

You will ensure compliance with ICH GCP and country-specific requirements, support business development activities, and collaborate with sponsors and project teams to deliver timely regulatory outcomes.

Qualifications

• 4+ years of college in medical, biological, physical, health, pharmacy or related science
• Two-year college degree with 8 years of clinical research experience (CRA/Reg Affairs)
• 5–7 years in pharmaceutical/CRO with senior regulatory or clinical start-up experience
• Proficient in cross-cultural communication and fluent in English

Responsibilities

• Review budgets and contracts; participate in business development; prepare regulatory proposals and feasibility reports.
• Coordinate regulatory and ethics submissions across EMEA, APAC and LATAM; track approvals.
• Provide regulatory guidance; communicate submission status to Sponsor, PM, CRAs and Medical & Scientific Affairs; prepare IMPDs and IBs.

Skills

Leadership

Strategic planning

Communication

Relationship management

Interpersonal skills

Multi-tasking

Education

Bachelor's degree in life sciences

Nursing degree or related life science degree

Job description

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs leader to guide submissions across EMEA, APAC and LATAM. You will coordinate regulatory and ethics submissions, mentor junior staff, and provide strategic regulatory guidance to drive successful clinical programs.

You will ensure compliance with ICH GCP and country-specific requirements, support business development activities, and collaborate with sponsors and project teams to deliver timely regulatory outcomes.