CMC Regulatory Specialist — Dossier & Lifecycle

Bausch & Lomb GmbH; Warszawa; Hybrid; PLN 150,000 - 210,000; Full time

Job summary

Bausch + Lomb is seeking a CMC Specialist to manage chemistry, manufacturing and controls information across regulatory dossiers and product lifecycles. The role focuses on accurate, compliant CMC documentation for marketing authorizations, variations and lifecycle changes, ensuring alignment with international guidelines.

The position requires at least 3 years in pharma regulatory affairs, strong English skills, and a collaborative, detail-oriented mindset. Hybrid work in Warsaw.

Qualifications

• Min 3 years in pharmaceutical industry preparing and maintaining regulatory docs for multiple markets.
• Knowledge of Regulatory Affairs CMC principles and pharmaceutical quality concepts.
• Scientific education in a technical field (pharmacy, chemistry, biology, life sciences).
• Understanding of international regulatory requirements (ICH, EU, FDA).
• Very good English skills; Polish is a plus.
• Strong organizational and communication abilities.

Responsibilities

• Prepare or support the quality (CMC) sections of regulatory dossiers (CTD Module 2.3/Module 3) and technical files.
• Prepare or support CMC documentation for initial marketing authorizations and lifecycle changes.
• Assess quality change control activities impacting the product portfolio and update CMC docs.
• Collect and review information from cross-functional departments for regulatory submissions.
• Coordinate responses to Deficiency Letters from Health Authorities on CMC topics.
• Serve as a CMC point of contact for internal and external stakeholders.
• Participate in cross-functional groups and regulatory projects related to CMC.
• Contribute to Regulatory activities with RA department interactions.
• Support CMC regulatory strategy for new and existing products.
• Ensure compliance with ICH, EU, FDA guidelines.
• Support continuous improvement of CMC documentation processes.

Skills

CMC principles

Regulatory affairs

English skills

Education

Scientific degree

Job description

Bausch + Lomb is seeking a CMC Specialist to manage chemistry, manufacturing and controls information across regulatory dossiers and product lifecycles. The role focuses on accurate, compliant CMC documentation for marketing authorizations, variations and lifecycle changes, ensuring alignment with international guidelines.

The position requires at least 3 years in pharma regulatory affairs, strong English skills, and a collaborative, detail-oriented mindset. Hybrid work in Warsaw.