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 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 seeking a curious and proactive Regulatory Affairs Manager to join our team. In this role, you will ensure that our products and processes comply with all relevant regulatory requirements. You will work cross-functionally with product development, quality assurance, and external regulatory bodies to ensure successful submissions and ongoing compliance. The ideal candidate will possess strong communication skills, and a passion for quality.
Key Responsibilities
* Provide regulatory support for international pharmaceutical marketing authorisations
* Plan, implement, and coordinate European procedures (MRP/DCP)
* Develop and execute strategic planning and implementation of variations in and outside Europe
* Establish and maintain relationships with regulatory authorities and relevant stakeholders
* Support local market units in regulatory tasks and submissions
* Monitor and interpret regulatory requirements and communicate updates to internal teams.
* Collaborate with cross-functional teams to ensure regulatory strategies are aligned with business goals.
Key Requirements
* Minimun 2-3 years of experience in regulatory affairs within the pharmaceutical industry
* University degree in sciences
* Solid knowledge of European regulatory procedures (MRP/DCP) and international regulatory frameworks
* Experience in managing variations, renewals, and regulatory lifecycle activities
* Strong communication skills and the ability to collaborate with global teams and external stakeholders
* Interest in regulatory IT topics
* Proficiency in English;
* High attention to detail and excellent organizational skills
What We Offer
* A dynamic, collaborative, and supportive work environment.
* 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: recrutamento.portugal@fresenius-kabi.com