Are you at the beginning of your Regulatory Affairs career and ready to take the next step in an international pharmaceutical company?
Medical Valley/Xiromed is a fast-growing generic pharmaceutical company focused on tender markets across Europe. Our mission is to make healthcare more sustainable by offering affordable medicines, enabling healthcare systems to reallocate resources to newer and more advanced treatments.
Headquartered in Höllviken, Sweden, we operate across Europe and are part of INSUD Pharma, a global pharmaceutical group based in Spain with more than 9,500 employees worldwide. We combine the entrepreneurial spirit and short decision-making paths of a growing organisation with the stability and resources of an international pharmaceutical group.
We are now looking for a Regulatory Affairs Associate who is ready to take the next step in their career and become part of our international team.
Curious to learn more about us? Read more on our website here.
About the Role
This is an opportunity for someone with initial experience in Regulatory Affairs who is ready to broaden their knowledge and take on increasing responsibility in an international pharmaceutical environment.
You will support regulatory submissions and lifecycle management activities across several European markets, working closely with experienced Regulatory Affairs colleagues as well as other functions within the organisation.
The role will give you exposure to different parts of the regulatory lifecycle, from marketing authorisation applications and national phase activities to renewals, regulatory documentation, artwork and ongoing portfolio management.
As your experience grows, you will have the opportunity to take greater ownership of regulatory activities and develop your knowledge across products and European markets.
You will report to the Regulatory Affairs Manager and join an international team of twelve colleagues, with three team members based in Sweden. The position is based at our head office in Höllviken, with a flexible hybrid working model, starting with a probationary period.
What You Will Do
Your responsibilities will include:
· Support the preparation of regulatory submissions and Marketing Authorisation Applications (MAAs)
· Compile and prepare regulatory documentation for submissions and lifecycle management activities
· Coordinate national phase activities, including translations of product information and artwork/mock-up updates
· Support renewals and other ongoing regulatory activities across the product portfolio
· Manage and maintain eCTD documentation
· Ensure regulatory databases, product information and essential documentation are kept up to date
· Follow up regulatory activities and communicate status and timelines to relevant stakeholders
· Work closely with colleagues within Regulatory Affairs, Supply Chain, Artwork and other functions
· Monitor European regulatory requirements and contribute to sharing relevant updates within the organisation
· Contribute to the continuous development of regulatory processes and ways of working
Who You Are
You have started building your career within Regulatory Affairs and are now looking for an environment where you can continue learning while gradually taking on greater responsibility.
You are curious, structured and comfortable working with several activities at the same time. You enjoy collaborating with others but are also motivated to take responsibility for your own tasks. You are communicative, adaptable and eager to develop your regulatory knowledge.
We believe you bring:
· A university degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or a related field
· Approximately 1–2 years of experience within Regulatory Affairs
· Knowledge of regulatory guidelines and EU pharmaceutical regulations, including GMP
· Knowledge of ICH guidelines and the CTD dossier structure
· Understanding of eCTD structure
· Native Swedish and fluent English, both written and spoken
Experience or knowledge within CMC, generic pharmaceuticals, decentralised procedures or European regulatory frameworksis an advantage but not a requirement. Spanish, German or another Nordic language is also considered an advantage.
Why Join Us
This is a great opportunity to build a broad foundation within Regulatory Affairs while working in an international pharmaceutical environment.
You will join a collaborative and supportive team where you can learn from experienced colleagues while gradually developing greater independence and responsibility. At the same time, Medical Valley/Xiromed offers the entrepreneurial environment of a growing organisation where ideas are encouraged and decision-making paths are short.
With ambitious growth plans across Europe, there are excellent opportunities to develop your Regulatory Affairs expertise and grow together with the company.
Application Process
In this recruitment, Medical Valley/Xiromed is collaborating with Agardh Recruitment & Consulting. If you have any questions regarding the position or the recruitment process, please contact Pernilla Agardh at +46 (0)72 249 94 80.
We review applications on an ongoing basis, so we encourage you to apply as soon as possible.
We look forward to hearing from you!
