Global CMC Regulatory Lead Scientist

7824-Janssen-Cilag Polska Sp. z o.o. Legal Entity; Poland; On-site; PLN 205,000 - 354,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a CMC Regulatory Lead based in Warsaw to drive global regulatory affairs across CMC and value chain teams. You will shape regulatory strategy, prepare dossiers for Health Authorities, and guide lifecycle management for multiple products and devices.

Strong cross-functional collaboration and regulatory expertise are essential. Ideal candidates hold an advanced degree with 8+ years in pharma/biopharma regulatory roles, and a proven track record in global submissions

Qualifications

• BS in biological, pharmaceutical, chemical or engineering sciences; MS/PhD preferred.

Responsibilities

• Lead CMC regulatory activities as the Regulatory Lead on global teams.
• Develop global CMC regulatory strategy for products and devices.
• Prepare regulatory dossiers for Health Authority submissions; ensure lifecycle compliance.

Skills

Regulatory affairs

CMC knowledge

Global regulatory

Cross-functional comms

Education

MS/PhD preferred

BS in bios/pharma/chem/engineering

Job description

Johnson & Johnson is seeking a CMC Regulatory Lead based in Warsaw to drive global regulatory affairs across CMC and value chain teams. You will shape regulatory strategy, prepare dossiers for Health Authorities, and guide lifecycle management for multiple products and devices.

Strong cross-functional collaboration and regulatory expertise are essential. Ideal candidates hold an advanced degree with 8+ years in pharma/biopharma regulatory roles, and a proven track record in global submissions