Would you like to be part of a growing biopharma company?
Hansa Biopharma is a commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.
Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.
Principal Responsibilities:
- Contribute to regulatory agency interactions
- Providing regulatory input to development projects
- Assist in coordinating the work of compiling regulatory applications e.g. CTA/INDs, Knowledge about CTIS is an advantage
- Assist in regulatory applications and Orphan status and marketing authorization applications and post-marketing activities.
- Working with product information, art work and national databases as well as review promotional and non-promotional materials and art work
- Engage local RA vendors input for local market activities post-marketing: e. g. vendor agreement, serialization-GTIN, local compliance adherence on promotional material, local abbreviated SmPCs for promotional purposes.
You will be part of a project group consisting of colleagues representing all disciplines within the company. In the role you will often have contacts with external parts –mainly consultants, and collaboration partners.
Professional Qualifications:
In order to succeed in this position, we believe that you have:
- A university degree within Life Sciences/Natural Sciences or equivalent.
- At least 5 years of experience from working in regulatory affairs
- Ability to learn and adapt in a fast and flexible manner
- Experience with applications to EMA/FDA
- Fluency in written and oral English
The following experience is of merit:
- Experience with clinical regulatory affairs and knowledge about CTIS
- Experience of working with orphan medicinal products
- Experience of working with serious diseases with unmet medical needs
- Experience of working with biotech products
- Relevant experience in working in an affiliate
Our culture and behaviours
Working at Hansa is more than a job for us and our culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:
- Self-motivated
- Doer
- Team player
Our people mean everything to us, and so our leaders, in addition to the above, must also be able to evidence the behaviours below:
- Brave
- Empathetic
- Lead-by-example
All these behaviours will be assessed at various stages of the recruitment process.
You as a person
As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organizational match in this role, we hope that you recognize yourself as having the following characteristics:
- Independent and well-structured taking ownership of your responsibilities, planning and working proactively
- Strong communication skills with the ability to listen with the intent to understand others and demonstrate clear communication. You are great at creating and maintaining good relationships with stakeholders inside and outside of
- Ability to drive decision-making and execute as needed
- Open-minded with the willingness to learn and embrace new perspectives
Hansa is for everyone
At Hansa we aspire to be a truly great place to work. We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple - hire the best person for the job.
Type of employment:
This is a permanent and full-time (40 hours) position.
Hansa Biopharma is based in Lund, Sweden and we apply flexible working hours with the option to work remotely to enable a good work-life balance. The starting date is February 1st or earlier is possible.
The process:
Please apply for the position through the following link. Applications should not be sent through any other platform.
Attach your CV and a cover letter in English only. Unfortunately, we are unable to review applications made in other languages.
The last day for applications is December 4, 2024, but we will review applications as they are received and may ultimately close the process earlier.
For questions regarding the position and process please contact the recruiting manager Zak Huang, zak.huang@hansabiopharma.com.
We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s mission!
Please note: No external recruitment support is required. Only applications received directly will be considered.
