Senior Manager, Regulatory Submissions | Remote

Bristol Myers Squibb; Warszawa; Hybrid; PLN 251,000 - 304,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager of Submission Management in Warsaw, Poland to lead end-to-end regulatory activities, including US IND and global health authority submissions. The role requires 7+ years of submissions experience and people management, with hybrid work options in a globally focused team.

Based in Poland, the role involves coordinating with global teams, ensuring regulatory compliance, and driving continuous improvement in submission processes while mentoring staff.

Qualifications

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies.
• Supports other RISM members, sharing expertise and guidance as SME.
• Communicates effectively in English and explains complex topics clearly.
• Applies project management methodologies and strategic thinking to define objectives, track progress and deliver results.
• Proficient with desktop software and able to instruct others.

Responsibilities

• Collaborate with stakeholders to define IND and marketing submission strategies and document requirements.
• Assess submission deliverables to ensure compliance and prepare eCTD dossiers for global markets.
• Drive the Global Submission Plan progress and ensure timely health authority submissions.
• Manage submission production activities and lifecycle management submissions with health authorities.

Skills

Regulatory strategy

Submission management

Cross-functional collaboration

English communication

Project management

Regulatory SME

Desktop software

Education

BA/BS degree in science/technology

Tools

Desktop software

Job description

Bristol Myers Squibb is seeking a Senior Manager of Submission Management in Warsaw, Poland to lead end-to-end regulatory activities, including US IND and global health authority submissions. The role requires 7+ years of submissions experience and people management, with hybrid work options in a globally focused team.

Based in Poland, the role involves coordinating with global teams, ensuring regulatory compliance, and driving continuous improvement in submission processes while mentoring staff.