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Regulatory Affairs Manager
2 semanas atrás
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.
Your Role
Ready to join our Portuguese affiliate? An exceptional opportunity has become available for a dynamic Regulatory Affairs (RA) Manager to join our RA department.
In this role you will be responsible for key regulatory activity, including any required Health Authority interactions for our organization, to ensure maintenance of Marketing Authorizations for the company's product portfolio. Tasks will be the life cycle management of the marketed product as well as registration of new compounds, including possible Early Access Programs for new assets. You will act as a point of contact for Health Authorities to maintain close relationships.
Key Responsibilities Include
- Drive in country submission management from planning to finalizing local submissions (incl. review and approval of dossiers, new documentation for label and artwork when applicable).
- Manage specific local requirements (including national product information, artworks, mock- ups when applicable) and manage country input and fees planning.
- Language dependent activities (artworks, promotional materials, national product information).
- Support Named Patient programs and Early Access Programs for new assets.
- Drive local cross-functional alignment and quality control of regulatory applications/documentation with regional/local regulatory requirements
- Contribute with RA input for cross-functionally crisis management such as quality alerts, stock-outs and maintain HA interaction.
- Provide relevant support for clinical trials as applicable.
- Review and approve promotional material.
Who You Are
- University degree (Master's or PhD) in pharmaceutical science or related subject.
- Minimum of 4+ years of experience in the regulatory affairs field.
- Ability to execute assigned task independently as well as working within a small team.
- Strong project management, attention to detail skills & proactive communication approach.
- High proficiency in English and Portuguese, both written & verbal.
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
