Global Regulatory Affairs Manager Submissions & Strategy

Worldwide Clinical Trials; Warszawa; On-site; PLN 210,000 - 320,000; Full time

Job summary

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs professional to lead complex submissions across EMEA, Asia Pacific and LATAM. You will mentor junior staff, provide strategic guidance on regulatory projects, and collaborate with sponsors and cross-functional teams to ensure regulatory success.

The role requires a strong background in medical/science education, extensive regulatory know-how, and ability to navigate diverse regulatory environments while maintaining

Qualifications

• Minimum four-year college curriculum in medical/biological/physical/health sciences or related field.
• Two-year college curriculum with eight years of clinical research experience (e.g., CRA, Reg Affairs).
• 5–7 years in pharmaceutical/CRO industry with senior regulatory or start-up experience.
• Proficient in cross-cultural communication and English (spoken and written).

Responsibilities

• Review study budgets and costing related to contract negotiations and bid defense meetings.
• Coordinate and manage regulatory and ethics submissions across EMEA, Asia Pacific and LATAM regions.
• Provide expert regulatory advice and communicate submission status with Sponsor, Project Manager, CRAs and Medical & Scientific Affairs staff.
• Train, coach and mentor junior staff; line management may be required.

Skills

Leadership

Regulatory affairs

English proficiency

Cross-cultural communication

Education

Bachelor's degree in life sciences

Two-year college curriculum in life sciences with 8 years of clinical research experience

Job description

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs professional to lead complex submissions across EMEA, Asia Pacific and LATAM. You will mentor junior staff, provide strategic guidance on regulatory projects, and collaborate with sponsors and cross-functional teams to ensure regulatory success.

The role requires a strong background in medical/science education, extensive regulatory know-how, and ability to navigate diverse regulatory environments while maintaining