Arbetsbeskrivning

We do nothing regular within regulatory!

Are you an experienced regulatory expert looking for a role where you can truly make an impact? At RegSmart you will help drug development companies navigate complex regulatory challenges in both the EU and US, from early development to clinical trials and beyond. As Senior Advisor you will provide high-level strategic advice as well as hands-on regulatory support. You will work across a variety of projects, often taking the lead, and collaborate closely with colleagues, clients and authorities. The role combines independence with teamwork in a dynamic, growing company.

Depending on your expertise and client needs, you may: • Develop regulatory strategies in pre-clinical and clinical phases, main focus is projects in early stages • Identify data gaps and guide clients on forward strategies • Interpret guidelines, or find new solutions when none exist • Prepare and review submissions for regulatory authorities • Lead or participate in scientific advice meetings with e.g. EMA or FDA • Serve as regulatory lead in development projects in collaboration 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 • Strong experience in regulatory strategies for drug development • Background from pharma industry, regulatory authority or consultancy • University degree in science or engineering, preferably with a PhD • Excellent command of English, spoken and written • Broad drug development knowledge, including preclinical phases We are looking for someone reliable, proactive and collaborative, who can analyze complex questions, build strong relationships and enjoy working independently as well as in a team. About RegSmart We combine regulatory expertise with commercial understanding and scientific experience. It is all about managing risks and expectations, making sure your time and resources are used wisely. We help you drive your work to the next phase, with eyes on both the bigger picture and the details. 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] 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.