Empresa:

Fresenius Kabi Portugal

Descrição da Função

The Company

Fresenius Kabi is a leading global health care company that offers life-saving medical devices and medicinal products. At Fresenius Kabi we are dedicated to excellence with no compromise on quality, teamwork through respectful collaboration, serving patients beyond expectations, innovating healthcare by learning with our customers and partners, and acting today for a better tomorrow while being mindful of future needs and resources, all grounded in over 100 years of heritage. One of our business units is specialized in the development, manufacturing, and commercialization of high-quality generic medicines. Our mission is to make essential healthcare more affordable and accessible to patients worldwide.

The Role

We are looking for a motivated and detail-oriented Regulatory Affairs CMC with experience in the pharmaceutical sector to join our growing team and contribute to the development of our generic's portfolio. In this role, you will be responsible for preparing and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, ensuring compliance with global regulatory requirements. The ideal candidate will possess strong communication skills, attention to detail, and a passion for quality.

Key Responsibilities

• Prepare and review CMC documents for regulatory submissions of drug products (NDAs, variations, etc.), ensuring accuracy and compliance
• Collaborate with cross-functional teams (R&D, regulatory affairs, manufacturing sites, quality assurance, etc.) to gather and summarize technical data
• Ensure all CMC documentation meets regulatory guidelines and company standards
• Communicate effectively with internal teams and external stakeholders
• Advise on strategy in the development and drive in the implementation of CMC strategies
• Contribute to continuous process improvements in CMC documentation

Key Requirements

• Minimum 2-3 years of experience in CMC writing
• University degree in sciences
• Strong understanding of CMC documentation requirements (EMA, ICH, etc.).
• Excellent written and verbal communication skills
• Detail-oriented with a focus on accuracy and regulatory compliance
• Motivated, proactive, and capable of working independently and as part of a team
• Ability to manage multiple projects and meet tight deadlines in a fast-paced environment
• Knowledge of regulatory guidelines specific to generics and the submission process is a plus
• Interest in regulatory IT topics

What We Offer

• A dynamic, collaborative, and supportive work environment in vicinity to one of our production units and laboratories
• Opportunities to grow within a leading global pharmaceutical company
• Competitive salary and benefits package
• Exposure to exciting and impactful projects

How to Apply

If you are passionate about the pharmaceutical industry and ready to take the next step in your career and be part of our team, we would love to hear from you!

Please send your application or ask more information to:

Observações

Viseu (Portugal)