Global Regulatory Documentation Lead for Submissions

Bristol Myers Squibb; Warszawa; On-site; PLN 230,560 - 279,377; Full time

Job summary

Bristol Myers Squibb is seeking a Regulatory Document Lead in Warsaw, Poland. This role involves leading the strategy and authoring of regulatory documents to support submissions and approvals across key markets.

The ideal candidate will have a PharmD/PhD or equivalent degree and at least 5 years of experience in regulatory documentation. You will collaborate with cross-functional teams to ensure high-quality submissions.

Compensation offered ranges from zł230,560 to zł279,377 depending on experience.

Qualifications

• PharmD/PhD in biological sciences or equivalent degree with 5 years of experience.
• Proven writing skills in regulatory documents such as IB and CSR.
• Ability to analyze and interpret complex scientific data.

Responsibilities

• Author regulatory documents for submission to health authorities worldwide.
• Maintain document prototypes and ensure quality and compliance.
• Manage timelines and facilitate cross-functional team communication.

Skills

Strong writing skills

Data analysis

Organizational skills

Communication skills

Interpersonal skills

Education

PharmD/PhD in relevant scientific discipline

Master’s/Bachelor’s degree with approximately 5 years of experience

Tools

Document management system

Job description

Bristol Myers Squibb is seeking a Regulatory Document Lead in Warsaw, Poland. This role involves leading the strategy and authoring of regulatory documents to support submissions and approvals across key markets.

The ideal candidate will have a PharmD/PhD or equivalent degree and at least 5 years of experience in regulatory documentation. You will collaborate with cross-functional teams to ensure high-quality submissions.

Compensation offered ranges from zł230,560 to zł279,377 depending on experience.