Global Regulatory Pre-Award Strategy Director

Worldwide Clinical Trials; Warszawa; On-site; PLN 361,240 - 509,986; Full time

Job summary

Worldwide Clinical Trials is seeking a Director of Regulatory Pre-Award Strategy to lead global regulatory affairs. This role requires strong communication and leadership skills as well as a deep understanding of clinical research principles. The Director will be accountable for ensuring high performance and regulatory compliance across projects.

The ideal candidate has significant experience within the pharmaceutical or CRO industry, proficient in MS-Office applications and regulatory tools. Join our mission to innovate and improve lives through quality regulatory expertise.

Qualifications

• Minimum of 10 years in pharmaceutical/CRO industry with senior level regulatory experience.
• Demonstrated ability to manage multiple tasks and solve complex problems.
• Proficient in cross-cultural communication and English.

Responsibilities

• Oversee regulatory affairs activities and team performance.
• Provide regulatory advice for internal and external projects.
• Ensure compliance with SOPs and regulatory standards.
• Prepare technical documentation according to study requirements.

Skills

Strong oral and written communication skills

Leadership and organizational management skills

Proficiency in MS-Office Applications

Understanding of clinical research principles

Interpersonal skills in a fast-paced environment

Education

Four-year college curriculum in relevant science

Two-year nursing degree or life science degree with 8 years experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Regulatory Portals

Worldwide Applications

Job description

Worldwide Clinical Trials is seeking a Director of Regulatory Pre-Award Strategy to lead global regulatory affairs. This role requires strong communication and leadership skills as well as a deep understanding of clinical research principles. The Director will be accountable for ensuring high performance and regulatory compliance across projects.

The ideal candidate has significant experience within the pharmaceutical or CRO industry, proficient in MS-Office applications and regulatory tools. Join our mission to innovate and improve lives through quality regulatory expertise.