Global Regulatory Documentation Lead

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 150,000 - 249,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Manager for Global Scientific and Regulatory Documentation to lead the strategy and authoring of regulatory documents for submissions and approvals in key markets. The role supports compliant, speed-focused communications across clinical pharmacology, clinical, and safety areas.

Based in Warsaw with a hybrid model and at least 50% onsite attendance, you will coordinate cross-functional input, maintain document prototypes, and ensure high-quality

Qualifications

• PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree.
• 2–4 years in regulatory documentation.
• Proven ability to author IB, CSR, protocols and safety reports.
• Ability to analyze complex scientific data across disciplines.
• Understanding of global pharmaceutical drug development.
• Strong organizational, communication, and interpersonal skills in cross-functional teams.
• Familiarity with document publishing processes.

Responsibilities

• Coordinate and author regulatory documents ensuring scientific, medical, and regulatory input is integrated.
• Use advanced document development tools to enhance efficiency and quality.
• Plan and manage timelines for all components of assigned documents.
• Contribute to document strategy sessions, messaging, flow, logic and consistency.
• Maintain document prototypes and shells, ensuring quality and timely completion.
• Review and edit documents as required while ensuring compliance.

Skills

Strong writing skills

Cross-functional collaboration

Regulatory document knowledge

Timeline management

Analytical skills

Education

PharmD/PhD or Master/Bachelor in relevant field

Tools

Document management system

Job description

Bristol Myers Squibb in Warsaw is seeking a Manager for Global Scientific and Regulatory Documentation to lead the strategy and authoring of regulatory documents for submissions and approvals in key markets. The role supports compliant, speed-focused communications across clinical pharmacology, clinical, and safety areas.

Based in Warsaw with a hybrid model and at least 50% onsite attendance, you will coordinate cross-functional input, maintain document prototypes, and ensure high-quality