Global CMC Regulatory Scientist — Principal

Biopharma Careers; Warszawa; Hybrid; PLN 205,000 - 354,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Health insurance

Job summary

Johnson & Johnson Innovative Medicine in Warsaw, Poland is seeking a Principal Scientist in Global CMC Regulatory Affairs. The role covers both pre- and post-approval activities, leading CMC regulatory strategy and dossier preparation for global submissions.

You will participate in global regulatory teams, drive continuous improvement, and ensure alignment with QTPP and lifecycle management. Minimum 8 years in relevant field; MS/PhD preferred.

Qualifications

• BS in biological, pharmaceutical, chemical or engineering sciences with at least 8 years in pharma or health care; advanced degree preferred.
• Strong ability to define regulatory strategy and translate it into global plans.
• Excellent written and spoken communication with health authorities and teams.

Responsibilities

• Act as the CMC Regulatory Lead on global teams and provide regulatory input to product development.
• Develop and execute global CMC regulatory strategies for synthetic drugs and delivery devices.
• Lead preparation of regulatory dossiers for submissions to health authorities.
• Develop buy-in on regulatory strategy and respond to health authority inquiries as needed.
• Maintain connectivity to global regulatory strategy and ensure lifecycle management alignment.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Effective communication

Education

BS in biological, pharmaceutical, chemical or engineering sciences

MS/PhD/PharmD preferred

Job description

Johnson & Johnson Innovative Medicine in Warsaw, Poland is seeking a Principal Scientist in Global CMC Regulatory Affairs. The role covers both pre- and post-approval activities, leading CMC regulatory strategy and dossier preparation for global submissions.

You will participate in global regulatory teams, drive continuous improvement, and ensure alignment with QTPP and lifecycle management. Minimum 8 years in relevant field; MS/PhD preferred.