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Location

Geretsried | Germany

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Job description

Regulatory Affairs Manager (gn) Design Control

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.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible. Aufgaben:

• Planning, writing and compilation of design control documents for Formycon's development programs with focus on drug-delivery combination products (e.g. prefilled syringes, auto injectors) including lifecycle activities
• Coordination of Design Control activities for Formycon's development programs with involved stakeholders (e.g. internal functional departments, external CMOs/CROs, device supplier, license partners)
• Development and implementation of drug-device combination development strategies during product development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the combination product development programs
• Review and approval of Design Control documents/risk-assessments/specifications/analytical protocols and reports from CMOs/CROs and internal functional departments
• Support compilation of Briefing documents and health authority interactions for the alignment of drug-delivery combination product development strategies
• Participation in technical project teams and point of contact for external partners and CMOs/CROs for combination product development topics
• Liaison with clinical department for design of human factor studies
• Contact partner for notified bodies for notified body assessment
• Regulatory compliance check of documents and evaluation of change controls

Qualifikationsprofil:

• Scientific background with bachelor or master degree preferably in biology, biotechnology, pharmaceutical sciences, chemistry or equivalent
• Minimum three years of experience in Medical Device Development area with focus on Design Control, Technical documentation and Risk Management for drug delivery systems
• Practical experience in compilation of Design Control/Technical documentation for drug delivery systems
• Experience with drug-device combination products and knowledge of corresponding EMA/FDA guideline requirements would be of advantage
• Very good team player, result oriented, well organized, proactive, problem solver and able to work independently
• Creativity and enthusiasm for working in a dynamic fast growing biopharmaceutical company
• Fluent in written and spoken English required, German knowledge is desirable
• Proficient in MS-Office
• German work permit is mandatory

Benefits:

• Flexible working time
• Hybrid work
• 30 days paid vacation
• Formycon pension
• Group accident insurance
• Formycon card
• Continuing education offers
• Team spirit, great working atmosphere and much more!

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Job tags

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Salary