CMC Specialist

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 (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 worldfrom 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, postapproval activities (variations, renewals) by providing highquality CMC documentation.

Key Responsibilities

1. 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.
2. Prepare or support the preparation, update, and maintenance of CMC documentation for: - Initial marketing authorization applications - Postapproval changes (variations) - Product lifecycle management (LCM).
3. 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.
4. Collect, request, and review approvalrelevant information and technical documentation from crossfunctional departments within the organization.
5. Coordinate and prepareresponses related to CMC topics to Deficiency Letters raised by Health Authorities.
6. Act as a CMC point of contact for internal and external stakeholders, including development, manufacturing, quality functions, andexternal manufacturing organizations.
7. Participate incrossfunctional working groups and regulatory projectsrelated to CMC topics.
8. Contribute to the Regulatory activities with suitable interaction with RA department.
9. Propose or support CMC regulatory strategy for new and existing products for example in Quality assessments
10. Ensure compliance with international regulatory guidelines and applicable regulations (e.g. ICH, EU, FDA).
11. Support continuous improvement of CMC documentation processes and regulatory standards.

Candidate Requirements

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

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