Regional Regulatory Affairs Specialist (all genders)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role can be done in hybrid working model, 3 days from the office in Warsaw, 2 days remote.
Your Role:
The Regulatory Affairs Specialist supports regulatory operational activities for international markets. The role focuses on coordinating regulatory activities, supporting audits/inspections and compliance topics, and ensuring smooth interaction between regional and local regulatory teams and work closely with different functions within RQS. We need your professiona experience with strong execution capability, attention to detail, and the ability to collaborate in a global environmental and work independently.
Who You Are:
- 3-6 years of overall experience in Regulatory Affairs, Strategy and Operations
- MSc in Pharmaceutical Sciences or related discipline
- Regulatory Knowledge: Solid understanding of EU and international regulatory requirements related to the life cycle management of authorized products. Expertise in Veeva Vault is beneficial but not essential.
- Compliance Monitoring: Oversee KPI tracking and compliance, identify and implement improvements to boost efficiency, compliance, and overall processes.
- Support: Assist with regional regulatory processes, projects, initiatives, and strategies.
- Audit and Inspection Readiness: Prepare for audits and inspections globally and address quality issues.
- Process Improvement: Lead initiatives to enhance processes, such as reviewing quality documents.
- Project Execution: Ensure timely delivery of project outcomes by effectively prioritizing tasks and managing resources to align with customer needs and business goals.
YOUR MAIN BENEFITS:
- Health and well-being: Get access to private medical care, life insurance, and sports card,
- Work-Life balance: Enjoy additional paid days off, hybrid working model.
- Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
- Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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R&D, Pharmaceutical, Network, Business Process, Oncology, Research, Science, Technology, Management, Healthcare