Pflichtpraktikum im Bereich Regulatory Affairs / Mandatory Internship in Regulatory Affairs Dep[...]

Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

We are looking for a fulltime intern to support our Regulatory Affairs team in Martinsried starting February/March 2025 for a period of approximately 6 months.

Your responsibilities

As a Regulatory Affairs Intern, you'll gain hands-on experience in the field of Regulatory Affairs CMC. You will support our team with administrative and coordination tasks and work with regulatory documents. This includes the following responsibilities:

• Review of source documents (complexity according to experience)
• Preparation of dossier templates
• Compilation and updates of regulatory documents/dossier modules, e.g. updates of stability modules, country specific updates for post-approval-changes (complexity according to experience)
• Formatting and finalization of regulatory documents, e.g. dossier modules
• Administrative tasks around preparation of regulatory documents and organization of department related documents, e.g. organizing approval cycles of dossier documents, setup and maintenance of folder structure and sharepoint
• Maintenance of trackers and logbooks
• Coordination of submissions, e.g. post-approval changes (complexity according to experience)
• Support for preparation of department-specific documents

Your qualifications

• Enrolled student (gn) who has to complete a compulsory internship
• Knowledge or experience in dealing with GMP standards and/or in the field of Regulatory Affairs would be desirable
• High sense of responsibility and an independent, reliable way of working
• A diligent and structured way of working with good attention to details
• An enquiring mind and good problem-solving skills
• An independent and pro-active personality
• Good written and spoken English, knowledge of German is an advantage

We offer

• Flexible working hours that can easily be combined with your studies
• Modern working environment
• Comprehensive induction programme
• Good transport connections, free company car park
• Flat hierarchies, short lines of communication and quick, joint decision
• Team spirit, great working atmosphere and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

For any questions, please feel free to send us an email at recruiting@formycon.com.