Regulatory Affairs Associate - Medical Valley/Xiromed

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.

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.

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.

Experience or knowledge within CMC, generic pharmaceuticals, decentralised procedures or European regulatory frameworks is an

advantage but not a requirement.

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.

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.