Regulatory Affairs Manager
On-siteUppsala, Uppsala, Sweden
Job Summary
Develop regulatory strategies for product development, registration, and lifecycle management across the global portfolio. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes and remove execution barriers. Independently prepare change requests, compile documents for marketing authorization, and issue release statements. Lead product registration projects, establish work procedures, and train the RA team on regulatory requirements and templates. Proactively monitor vigilance processes and communicate clear strategies to enhance time-to-market while maintaining compliance standards.
Required Qualifications
- Fluent in English, both spoken and written
- University degree in natural, pharmaceutical or technical science
- 5+ years of experience within the regulated pharmaceutical, life science, MD or IVD industries
- Knowledge of relevant standards (e.g. ISO 13485, ISO 23640, ISO 14971, ISO 18113, ISO 15223)
- 6+ years of profound regulatory experience working with authorities worldwide
- Thorough understanding of international regulations
- Strong leadership, including meeting management, presentation skills and coaching
- Results driven and team-oriented with the ability to influence outcomes as necessary
- Excellent organizational and time management skills
- Excellent communication skills
- Ability to communicate orally, in written documents, and in formal presentations
- Awareness of and sensitivity to cultural diversities
- Practical AI literacy, including the ability to use AI-enabled tools responsibly to improve efficiency, support analysis, and enhance the quality of deliverables
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.