Director, Global Regulatory Affairs

hace 4 semanas


Barcelona, España AstraZeneca A tiempo completo

Are you **passionate about science **and **experienced within regulatory affairs and drug development**? Do you possess **strategic and operational leadership skills?** Then, join us at **Respiratory and Immunology (R&I) regulatory affairs** to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio

At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines and patients.

**The role**:
We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the role as **Global Regulatory Affairs Director.** This role can be based at AstraZeneca’s dynamic R&D sites in **Gothenburg (Sweden) or Barcelona (Spain).**

**What you’ll do**:
As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.

The **Global Regulatory Affairs Director **is accountable for leading the development and implementation of the global regulatory strategy for a project or a group of products of increasing complexity within the R&I portfolio. You will ensure that the strategy is designed to deliver rapid approval with advantageous labelling in keeping with the properties of the products and the needs identified by the business, markets and patients.

**Do you have the essential qualifications for this role?**:
It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from the latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization.
- Advanced academic degree in a science related field
- Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development (more than 7 years)
- Proven track record of regulatory drug development including product approval/launch.
- Ability to work strategically within a complex, business critical and high-profile development program.

To be a successful in this role, we believe that you have a broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. Previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.) would be an advantage.

**Desirable Requirements**:
Experience and knowledge within the Respiratory or Immunology disease areas is an advantage, but not a formal requirement.

**So, what’s next?**:
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you

**Where can I find out more?**:
AZ Gothenburg

Respiratory & Immunology



  • Barcelona, España AstraZeneca A tiempo completo

    Do you have leadership skills and an in depth knowledge within **Regulatory Affairs? **Do you want to work on **innovative projects** of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win,...


  • Barcelona, España Consult Search A tiempo completo

    **Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...


  • Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...


  • Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...


  • Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Location: Barcelona, Spain Job reference: R-193794 Date posted: 03/04/2024 **This is what you will do**: The Associate Director, Global Regulatory Affairs Development Strategy (GRA-DS) will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex...


  • Barcelona, España AstraZeneca A tiempo completo

    Are you **passionate about science **and **experienced within regulatory affairs and drug development**? Do you possess **strategic and operational leadership skills?** Then, join us at **Respiratory and Immunology (R&I) regulatory affairs** to get involved in the global regulatory strategies and support the research, development and commercialization of our...


  • Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology...


  • Barcelona, España Tempus A tiempo completo

    **Passionate about precision medicine and advancing the healthcare industry?** Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing...


  • Barcelona, España Instituto Grifols SA A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • Barcelona, España AstraZeneca A tiempo completo

    The Executive Director EUCAN provides global strategic regulatory expertise and oversight to support the EUCAN countries and integrate the EUCAN countries into the global Regulatory Affairs network of AstraZeneca. The Executive Director EUCAN organizes the relevant Marketing Companies (MC) network and ensure their regulatory organizations are included in the...


  • Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Location: Barcelona, Spain Job reference: R-201477 Date posted: 06/05/2024 **This is what you will do**: The Senior Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of...


  • Barcelona, España Alira Health A tiempo completo

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...


  • Barcelona, España Alira Health A tiempo completo

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...


  • Barcelona, España AstraZeneca A tiempo completo

    This role coordinates and drives the Business Strategy for EUCAN Marketing Company Regulatory Affairs (EUCAN MCRA) including the digital agenda, simplification, and improvement projects in close collaboration with the Executive Director EUCAN, Senior Regional Director EU and EUCAN Marketing Company Regulatory Affairs (MCRA) Heads and all relevant Global...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Location: Barcelona (on-site) Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. Within Oncology Regulatory Science, Strategy &...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Location: Barcelona (on-site) Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. Within Oncology Regulatory Science, Strategy &...


  • Barcelona, España AstraZeneca A tiempo completo

    Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the...


  • Barcelona, España AstraZeneca A tiempo completo

    **This opportunity is available at our Gaithersburg, MD & Waltham, MA (USA), Mississauga (Canada), or Barcelona (Spain) locations.** Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all...

  • Regulatory Affairs

    hace 3 días


    Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completo

    Grupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory Affairs Se responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....


  • Barcelona, España AstraZeneca A tiempo completo

    **Are you a strategically focused Regulatory Affairs professional and would like to play a central role in crafting innovative drug development strategies and gaining fast, efficient regulatory approvals? If so, read on...** **At AstraZeneca, we work with a diverse set of minds, all united by a shared passion to learn, grow and discover**. **Who we...