Immedica's Regulatory Affairs department which currently consists of sixteen people is looking for a temporary regulatory associate to cover an upcoming 1 year maternity leave, preferably starting in December 2025. If you want to grow and develop within Regulatory Affairs at an expansive Swedish parent company with a focus on specialty pharmaceuticals in a global environment, this is the perfect opportunity.
In this position, the primary task will be managing regulatory life-cycle updates of well-established nationally approved products, mostly sterile ophthalmology products for European markets.
This could be to prepare and compile regulatory documents required for variations, renewals, responses to agency requests or other compliance updates including work with Product information and artwork as well as updates to national databases and catalogue texts.
You will be part of the regulatory department and join a smaller team working closely with other functions of the company, such as QA, Manufacturing and Supply to secure the quality and supply of the products. This is a 12-months parental leave cover position, based at Torsplan, Stockholm, starting as soon as possible. You will report to team-lead of Regulatory Specialty Care group.
Responsibilities
The role of Global Regulatory Associate includes:
- Regulatory responsibility with a focus on MAH products in Europe
- Participate in cross-functional internal projects as a regulatory expert for assigned products
- Coordination and approval of translations of product information (summary of product characteristics, labeling and package inserts) with the help of translators and local consultants
- Coordination and approval of artwork updates in collaboration with graphic designers and contract manufacturers
- Participate in updates and implementations of relevant SOPs
Experience and competence
We are looking for someone with a university degree in pharmacy/chemistry/biotechnology or equivalent, preferably with a few years of experience working in the pharmaceutical industry, preferably in regulatory affairs.
Experience working with electronic document management systems is an asset. CMC experience is an asset, but not a requirement. Excellent knowledge of Swedish and English, both spoken and written, is essential.
Personal Qualities
As a person, you are independent, ambitious, clear and meticulous. You have good teamwork skills and enjoy taking on new things. The ability to structure, obtain information and investigate information that is new to you is valued.
We welcome applicants from all backgrounds, and we encourage you to apply even if you feel you do not match 100% of the technical requirements. We celebrate diversity, promote inclusivity, place great emphasis on personal qualities and alignment with the company’s core values.
How to apply
If you wish to apply for this position, send your application to [email protected]. Applications are reviewed on an ongoing basis, and we encourage you to apply as soon as possible.
About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology and specialty care. Immedica was founded in 2018 and employs today around 150 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo.
At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues. Open & Honest: We foster transparency, integrity, and trust through open communication. Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape. Empowered: We encourage collaboration and ownership, creating a supportive workplace where the contribution of every team member drive innovation and growth.
