Job Position: Global Regulatory Affairs Manager
Location:
[Portugal: Tondela
home office 2-3 days per week]
Employment Type:
[Full-Time/Contract]
Experience Level:
2-3 years
About Us:
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.
We are looking for a dedicated and knowledgeable
Regulatory Affairs Manager
to join our growing team and contribute to the development of our generic's portfolio.
Position Overview:
As part of our Global Regulatory Affairs team, you will play a key role in ensuring that our medicines reach patients safely and efficiently. You'll lead regulatory strategies, manage submissions across Europe and beyond, and collaborate with cross-functional teams and regulatory authorities to drive successful submissions and lifecycle management. This is your chance to take ownership of strategic projects and make a real impact in a company that values innovation, quality, and teamwork.
Key Responsibilities
· Lead and coordinate regulatory activities for our medicines portfolio
· Plan and manage European procedures (MRP/DCP)
· Provide regulatory support for international pharmaceutical marketing authorisations
· Develop and execute strategic planning and lifecycle management in and outside Europe
· Build strong relationships with regulatory authorities and internal 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:
· Experience in regulatory affairs (pharma industry)
· University degree in sciences
· Solid knowledge of European regulatory procedures (MRP/DCP) and international frameworks
· Experience in managing variations, renewals, and regulatory lifecycle activities
· Strong communication skills and the ability to work with global teams and external stakeholders
· Proficiency in English; interest in regulatory IT topics
· Detail-oriented, proactive, and eager to take on responsibility
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 that improve patient access to medicines
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 submit your resume and cover letter via recrutamento.-