Global CMC Regulatory Scientist – Principal

Johnson Johnson; Warszawa; On-site; PLN 205,000 - 354,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

Johnson & Johnson in Warsaw, Poland, seeks a Principal Scientist in Global CMC Regulatory Affairs to lead regulatory strategy for synthetic modalities, covering pre- and post-approval activities. The role is based in Warsaw and focuses on global submissions and regulatory compliance.

The candidate will drive CMC regulatory plans, coordinate with Health Authorities, and ensure alignment with global strategy across teams and products.

Qualifications

• Broad knowledge of CMC regulatory requirements.
• Ability to develop global regulatory strategies for synthetic drugs and devices.
• Experience leading regulatory dossiers for global submissions.

Responsibilities

• Acts as CMC Regulatory Lead on global teams and provides regulatory input.
• Develops global submission plans compliant with local requirements.
• Drives CMC regulatory strategy for multiple products across lifecycle.
• Prepares regulatory dossiers for Health Authority submissions.
• Interacts with Health Authorities to resolve regulatory questions.

Skills

Regulatory leadership

CMC regulatory

Global regulatory strategy

Dossier preparation

Health authority communication

Regulatory planning

Cross-functional collaboration

Education

BS in biological/pharmaceutical/chemical/engineering

MS/PhD/PharmD preferred

Job description

Johnson & Johnson in Warsaw, Poland, seeks a Principal Scientist in Global CMC Regulatory Affairs to lead regulatory strategy for synthetic modalities, covering pre- and post-approval activities. The role is based in Warsaw and focuses on global submissions and regulatory compliance.

The candidate will drive CMC regulatory plans, coordinate with Health Authorities, and ensure alignment with global strategy across teams and products.