CMC Regulatory Specialist (Hybrid)

Bausch + Lomb; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

Bausch + Lomb in Warsaw, Poland, seeks a CMC Specialist to manage the preparation, maintenance and lifecycle management of CMC information within regulatory dossiers.

You will ensure compliance with ICH, EU and FDA guidelines, collaborate with cross-functional teams, and support regulatory submissions and post-approval changes. Strong English skills are required; Polish language is a plus, and a scientific degree is expected.

Qualifications

• At least 3 years of experience preparing and maintaining regulatory documentation for multiple markets.
• Solid knowledge of Regulatory Affairs CMC principles and pharmaceutical quality concepts.
• Scientific university degree (e.g., pharmacy, chemistry, life sciences).
• Good understanding of ICH, EU and FDA regulatory requirements.
• Strong English skills; Polish is a plus.
• Excellent organizational and communication skills.

Responsibilities

• Prepare or support CMC sections of regulatory dossiers (CTD Module 2.3 and 3; technical file) for marketing authorization and lifecycle submissions.
• Maintain CMC documentation for initial marketing authorizations and postapproval changes (variations).
• Coordinate and review information from crossfunctional departments; respond to Health Authority deficiency letters.
• Act as a CMC point of contact for internal and external stakeholders across development, manufacturing, quality, and external CMOs.
• Contribute to regulatory projects and continuously improve CMC documentation processes and standards.

Skills

Regulatory affairs knowledge

CMC principles

Pharmaceutical quality concepts

English proficiency

Organizational skills

Communication skills

Education

Scientific university degree

Job description

Bausch + Lomb in Warsaw, Poland, seeks a CMC Specialist to manage the preparation, maintenance and lifecycle management of CMC information within regulatory dossiers.

You will ensure compliance with ICH, EU and FDA guidelines, collaborate with cross-functional teams, and support regulatory submissions and post-approval changes. Strong English skills are required; Polish language is a plus, and a scientific degree is expected.