Job Position: Regulatory Affairs CMC Officer (Generics Pharmaceuticals)
Location: (Portugal: Tondela, home office 2-3 days per week)
Employment Type: (Full-Time/Contract)
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 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. We are looking for a motivated Regulatory Affairs CMC Officer to join our growing team and contribute to the development of our generic's portfolio.
Position Overview:
We are seeking an enthusiastic and detail-oriented Regulatory Affairs CMC Officer to join our team. This role is ideal for individuals with a scientific background who are eager to develop their expertise in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical industry. You will support the preparation and review of CMC documentation for regulatory submissions, ensuring compliance with global regulatory requirements. This is a great opportunity to learn, grow, and contribute to impactful projects in a collaborative environment.
Key Responsibilities
* Assist in preparing and reviewing CMC documents for regulatory submissions (e.g., NDAs, variations, etc), ensuring accuracy and compliance.
* Collect and organize technical data from cross-functional teams (R&D, manufacturing, quality assurance, etc.).
* Support the maintenance of CMC documentation in line with regulatory guidelines and company standards.
* Collaborate effectively with internal teams and external partners to facilitate timely submissions.
* Stay informed about relevant regulatory requirements and industry best practices.
Key Requirements:
· University degree in a scientific discipline (Pharmacy, Chemistry or related field).
· Interest in developing knowledge of CMC documentation requirements (EMA, ICH, etc.).
* Excellent written and verbal communication skills.
* Strong attention to detail and commitment to accuracy.
* Motivated, proactive, eager to learn, and capable of working independently and as part of a team.
* Knowledge of regulatory guidelines specific to generics process is a plus.
* Interest in regulatory IT tools and digital solutions is an advantage
What We Offer:
* A dynamic and supportive work environment close to one of our production units and laboratories.
* Comprehensive training and mentorship to develop your expertise.
* Opportunities for career growth within a leading global pharmaceutical company.
* Competitive salary and benefits package.
* Exposure to exciting and impactful projects that improve patients' lives.
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