Remote EMEA Regulatory Affairs Manager

Worldwide Clinical Trials; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to lead submissions across EMEA, APAC and LATAM and support business development with regulatory input.

Roles include preparing technical documents, mentoring junior staff, and ensuring compliance with ICH GCP and country-specific requirements. Strong leadership and cross-cultural communication are essential for success in a global CRO environment.

Formación

• Bachelor’s degree or higher in medical/biological/health science or related field.
• 8+ years in clinical research (CRA/Reg Affairs) for life sciences roles.
• 5–7+ years in pharmaceutical/CRO with senior regulatory or start‑up experience.
• Proficient in cross‑cultural communication and English proficiency.

Responsabilidades

• Review budgets and costing, participate in negotiations, and attend bid defense meetings.
• Coordinate regulatory & ethics submissions across EMEA, APAC and LATAM and maintain approvals.
• Provide regulatory guidance and contribute to project work, communicate status with Sponsor and teams, prepare IMPDs/IBs.
• Mentor/coach junior staff; line management may be required.

Conocimientos

Leadership

Planning

Communication

Relationship-building

Interpersonal skills

Multitasking

Educación

Bachelor’s degree in life sciences or related field

Two-year college + life science degree with 8 years in clinical research

Descripción del empleo

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to lead submissions across EMEA, APAC and LATAM and support business development with regulatory input.

Roles include preparing technical documents, mentoring junior staff, and ensuring compliance with ICH GCP and country-specific requirements. Strong leadership and cross-cultural communication are essential for success in a global CRO environment.