Global Regulatory Documentation Lead (Senior Manager)

Bristol-Myers Squibb; Poland; Hybrid; PLN 207,000 - 253,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager to lead document strategy and authoring for global regulatory submissions. You will coordinate and produce critical regulatory documents across disciplines, ensuring consistency and compliance while supporting fast information flow during development and approvals.

The role requires managing timelines, collaborating with cross-functional teams, and maintaining document prototypes and shells in a hybrid on-site 50% model.

Qualifications

• PharmD/PhD or Master’s/Bachelor’s degree in a relevant scientific field.
• 5 years of pharmaceutical regulatory documentation.
• Strong writing and editing skills for regulatory documents (IB, CSR, etc.).
• Ability to interpret complex data from diverse scientific disciplines.
• Understanding of global drug development and regulatory documentation requirements.
• Excellent time management and cross-functional collaboration.

Responsibilities

• Authors complex clinical documents (IB, Protocols, CSR, etc.) for submission to health authorities worldwide.
• Participate in document subteams and manage timelines for all components.
• Engage in document strategy sessions, messaging and flow for projects.
• Maintain document shells and prototypes; ensure consistency and quality.
• Coordinate with external documentation support when required and ensure standards.

Skills

Strong writing skills

Data interpretation

Regulatory documentation

Timeline management

Cross-functional collaboration

Education

PharmD/PhD or Master’s/Bachelor’s degree

Job description

Bristol Myers Squibb in Warsaw is seeking a Senior Manager to lead document strategy and authoring for global regulatory submissions. You will coordinate and produce critical regulatory documents across disciplines, ensuring consistency and compliance while supporting fast information flow during development and approvals.

The role requires managing timelines, collaborating with cross-functional teams, and maintaining document prototypes and shells in a hybrid on-site 50% model.