CMC Specialist - Regulatory Submissions & Lifecycle

Bausch + Lomb; Polska; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

Bausch + Lomb in Warsaw, Poland is seeking a CMC Specialist to manage lifecycle and documentation for regulatory dossiers across pharmaceuticals, medical devices, food supplements and cosmetics.

You will ensure compliant CMC data, support submissions, variations, renewals, and collaborate with cross-functional teams to collect documents and respond to health authority requests.

Hybrid role in a global eye health leader offering strong collaboration and development opportunities.

Qualifications

• Strong knowledge of regulatory CMC principles.
• Good command of English; Polish helpful.
• Excellent organizational and communication skills.

Responsibilities

• Prepare/update quality (CMC) sections of regulatory dossiers (CTD Module 2.3/Module 3).
• Maintain CMC documentation for marketing authorizations and lifecycle changes.
• Coordinate information from cross-functional teams for regulatory submissions.

Skills

CMC regulatory knowledge

English proficiency

Organizational skills

Communication skills

Cross-functional collaboration

Polish language (nice to have)

Education

Scientific university degree (e.g. pharmacy, chemistry, life science)

Job description

Bausch + Lomb in Warsaw, Poland is seeking a CMC Specialist to manage lifecycle and documentation for regulatory dossiers across pharmaceuticals, medical devices, food supplements and cosmetics.

You will ensure compliant CMC data, support submissions, variations, renewals, and collaborate with cross-functional teams to collect documents and respond to health authority requests.

Hybrid role in a global eye health leader offering strong collaboration and development opportunities.