Senior Manager, Global Regulatory Documentation

Biopharma Careers; Warszawa; On-site; PLN 231,000 - 279,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager to coordinate and author regulatory documents for submissions across markets. You will integrate scientific, medical and regulatory input from diverse teams to ensure timely, compliant documentation.

The role emphasizes global regulatory knowledge, strong writing ability, and collaboration across clinical, safety and development functions. Hybrid onsite with at least 50% presence in the office.

Qualifications

• 5+ years of pharmaceutical regulatory documentation experience.
• Strong writing and editing skills for IB, CSR, and related documents.
• Ability to analyze complex data and coordinate input from cross-functional teams.
• Knowledge of global regulatory requirements and document publishing processes.

Responsibilities

• Lead authoring of regulatory documents (IBs, Protocols, CSR, CTD summaries) for submissions and approvals.
• Use document development tools that incorporate AI, structured content, and advanced features to improve efficiency and quality.
• Plan and manage timelines with cross-functional teams across development stages.
• Review and edit documents to ensure consistency and accuracy with regulatory standards.
• Act as liaison for external documentation support and maintain good documentation principles.

Skills

Regulatory documentation

Scientific writing

Cross-functional collaboration

Medical writing

Education

PharmD/PhD or Master/Bachelor degree

Job description

Bristol Myers Squibb in Warsaw is seeking a Senior Manager to coordinate and author regulatory documents for submissions across markets. You will integrate scientific, medical and regulatory input from diverse teams to ensure timely, compliant documentation.

The role emphasizes global regulatory knowledge, strong writing ability, and collaboration across clinical, safety and development functions. Hybrid onsite with at least 50% presence in the office.