EMEA Regulatory Affairs Lead (Remote)

Worldwide Clinical Trials; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs professional to lead submissions across EMEA, APAC and LATAM. You will provide expert regulatory guidance, coordinate with ethics committees, and support clinical start-up activities.

The role requires a strong background in ICH GCP, cross-cultural communication, and fluency in English; you will mentor junior staff and help drive contract negotiations.

Qualifications

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related life sciences.
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience in clinical research.
• Minimum 5-7 years within the pharmaceutical/CRO industry, with senior regulatory or clinical start-up experience.
• Proficient in cross-cultural communication and fluent in English.

Responsabilités

• Review and prepare regulatory submissions and feasibility reports, participate in bid defense meetings.
• Coordinate and manage regulatory and ethics committee submissions across EMEA, APAC and LATAM.
• Provide regulatory advice and contribute to project work, communicate submission status to sponsors and managers.
• Mentor and train junior staff, with potential line management responsibilities.

Connaissances

Leadership

Project planning

Communication

Relationship building

Interpersonal skills

Multi-tasking

Formation

Four-year degree in life sciences

Two-year degree + life sciences background

Description du poste

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs professional to lead submissions across EMEA, APAC and LATAM. You will provide expert regulatory guidance, coordinate with ethics committees, and support clinical start-up activities.

The role requires a strong background in ICH GCP, cross-cultural communication, and fluency in English; you will mentor junior staff and help drive contract negotiations.