CMC Specialist

Bausch & Lomb GmbH; Warszawa; On-site; 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

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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

CMC Specialist

Location: Warsaw - Poland

Employment type: Full-time

Hybrid work: yes

Role Overview

The CMC Specialist is responsible for the preparation, maintenance and life cycle management of CMC (Chemistry, Manufacturing, and Controls) information within regulatory dossiers for pharmaceutical and medical device products, food supplements and cosmetics.

The role ensures that CMC documentation is accurate, consistent, and compliant with applicable regulatory requirements, manufacturing site documentation, and international guidelines throughout the product lifecycle.

The CMC specialist contributes to the regulatory submissions, post‑approval activities (variations, renewals) by providing high‑quality CMC documentation.

Key Responsibilities

• Prepare or support the preparation, authoring, and updating the quality (CMC) sections of regulatory dossiers, including CTD Module 2.3 and Module 3 and technical file, for marketing authorization applications and lifecycle submissions.
• Prepare or support the preparation, update, and maintenance of CMC documentation for: - Initial marketing authorization applications - Post‑approval changes (variations) - Product lifecycle management (LCM).
• Prepare or support the assessment of quality change control activities impacting the product portfolio and prepare and/or update the required CMC documentation for regulatory assessment.
• Collect, request, and review approval‑relevant information and technical documentation from cross‑functional departments within the organization.
• Coordinate and prepareresponses related to CMC topics to Deficiency Letters raised by Health Authorities.
• Act as a CMC point of contact for internal and external stakeholders, including development, manufacturing, quality functions, and external manufacturing organizations.
• Participate incross‑functional working groups and regulatory projectsrelated to CMC topics.
• Contribute to the Regulatory activities with suitable interaction with RA department.
• Propose or support CMC regulatory strategy for new and existing products for example in Quality assessments
• Ensure compliance with international regulatory guidelines and applicable regulations (e.g. ICH, EU, FDA).
• Support continuous improvement of CMC documentation processes and regulatory standards.

Candidate Requirements

• Strong professional experience, min 3 years in pharmaceutical industry in preparing and maintaining regulatory documentation for different markets.
• Good knowledge ofRegulatory Affairs CMC principlesand pharmaceutical quality concepts.
• Scientific education, e.g. a scientific (technical) university degree (e.g. pharmacy, chemistry, food chemistry, biology, life science, pharmaceutical management).
• Understanding of international regulatory requirements (e.g. ICH, EU, FDA).
• Very good English skills, Polish is nice to have.
• Organizational and communication skills.

This position may be available in the following location(s):