Vacant job

We do nothing regular within regulatory!

Have you worked with CMC to secure pharmaceutical quality in the development of biologics? At RegSmart you will use your expertise to guide companies developing biologics and ATMP through complex regulatory challenges.

As Senior Advisor you will support clients with both strategy and hands-on work. You will manage multiple projects, sometimes in a leading role, working closely with experienced colleagues while enjoying a high degree of independence.

• Drive regulatory CMC development plans for biologics and ATMP
• Prepare and review regulatory documentation
• Lead and participate in scientific advice meetings
• Interpret guidelines, or find new solutions when none exist
• Manage and coordinate CMC projects with clients and partners

This is a permanent full-time role. Our office is in Uppsala, with the possibility of hybrid work. For other locations, there are options to join co-working spaces such as Forskaren in Solna.

Qualifications

• Solid experience in ensuring pharmaceutical quality for biologics or ATMPs in drug development phases.
• Background from pharma, regulatory authority or consultancy
• Degree in science/engineering, preferably PhD
• Excellent English skills, spoken and written
• Experience with biologics and/or ATMPs

About RegSmart

We combine regulatory expertise with commercial understanding and scientific experience. After all, it is all about managing risks and expectations. Making sure that your time and money is spent in the best way. Spearheading your work to the next phase. Always with eyes both on the bigger picture and the details. Because both are essential for the end result.

www.regsmart.se

Application and contact

RegSmart is working with Search4S in this recruitment. Please contact Anna Rennermalm for more information. Interviews will be held on an ongoing basis.

• Phone: +46 70 794 20 05
• Email: [email protected] (mailto:[email protected])

Last application date: Sept 28th 2025

Kindly submit your application through the application link. Please note that RegSmart is not able to sponsor work visas for this position.