Project Manager – Drug Handling License (part-time)

Haselmeier Czech Republic (HMCZ), part of the medmix group, is expanding its activities in the field of medical devices and combination products. To support this strategic development, we are looking for an experienced Project Manager to lead the implementation and approval of a Drug Handling License (Manufacturing Authorisation according to article 40 of Directive 2001/83/EC) in the Czech Republic.

The role is designed as a project-based, part-time position (up to 0.4 FTE), with the possibility of continuation in case of successful delivery and launch of further expansion projects.

• Lead and deliver the project to obtain the Drug Handling License from the Czech authority (SÚKL)
• Prepare, coordinate and submit all required documentation for the license application
• Actively communicate with SÚKL and manage all regulatory interactions related to the approval
• Collaborate with the Drug Delivery Quality and RA team in Stuttgart to set-up a site GMP concept aligned with global drug delivery and healthcare standards
• Analyze existing Haselmeier processes (especially from German sites) and adapt them to Czech regulatory, process and infrastructure requirements
• Create, review and implement SOPs, work instructions, process maps and records related to drug handling
• Coordinate activities across Quality, Operations, Regulatory Affairs and Engineering teams
• Actively collaborate with colleagues in Germany (Buchen, Stuttgart) and transfer best practices to HMCZ
• Support preparation for inspections and audits related to the Drug Handling License

Qualifications

• Secondary or university degree; degree in pharmacy, veterinary medicine, chemistry, pharmaceutical technology, biology or related fields is a strong advantage
• Proven experience in project management, preferably in a regulated environment
• Experience in pharmaceutical, biotech or medical device industry is a strong advantage (quality field is minimum requirement)
• Solid understanding of EU and Czech GMP regulatory requirements for pharmaceuticals, experience with combination products is a plus
• Ability to translate complex regulatory and quality requirements into structured project execution
• Strong organizational and communication skills
• High level of reliability, accuracy and proactive mindset
• Fluent Czech (C1/C2), English at minimum B2 level (active communication with international teams)
• Good working knowledge of MS Office

Additional Information

medmix is an equal opportunity employer and believes in the power of a diverse workforce.
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About the Company

About Haselmeier

Haselmeier, part of the medmix Group, has been a well-established company in the healthcare market for more than 100 years. With around 250 employees, Haselmeier has been a pioneer in the development of injection pens for subcutaneous application since the 1960s.

We continue to introduce innovations in the field of self-injection pens, covering the entire process — from design and manufacturing to packaging and delivery. We have developed scalable solutions for a range of pharmaceutical partners, always applying state-of-the-art technologies — and our goal is to continue evolving even further.

Our products are designed with patients in mind. Our injection devices are used across various therapeutic areas, helping patients living with diabetes, supporting fertility treatments, and even offering options for low-energy cancer therapy.