Why choose AstraZeneca Spain?
AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.
We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Diverse collaborators
This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.
Cutting-edge innovators
When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.
Resilient trailblazers
Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.
Agile movers
Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.
Responsibilities
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 & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Associate Director of Translational Regulatory Science provides strategic and regulatory leadership to the development, commercialization, and life cycle management of assigned product(s) with a specific focus on translational areas. Translational areas are development opportunities that take place in cross-functional teams and focus on biomarkers or approaches such as the development of novel therapeutics, endpoints, in vitro diagnostics (IVDs), regulatory innovations, or the introduction of digital therapeutics in development programs. This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects, which meet regulatory agencies’ requirements. The Associate Director of Translational Regulatory Science interfaces between the functional areas involved in these projects, participates in the projects as a team member, and helps identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stages of development or through an ongoing development program. The Associate Director of Translational Regulatory Science plays a key role in working closely with the Regulatory Affairs Directors (RADs) assigned to development programs and contributes to product development by organizing regulatory authority interactions dedicated to focused topics to be an integral part of a development program.
In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.g., ctDNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process. The impact and visibility of this position are high, with implications for regulatory decisions, timelines, and advancement for the company in contributing to the ORSSE "Roadmap" implementation.
If you are a Regulatory professional with a passion for Oncology and want to make a difference in the lives of cancer patients, please apply to join our team at AstraZeneca.
Typical Accountabilities, What You will be Doing
- Guide the development of global regulatory strategies to facilitate the advancement of early and late Oncology programs, including those that involve innovative biomarkers, technologies, and therapeutics. Collaborate with project teams and other functions as necessary to ensure seamless integration of these elements into regulatory risk assessment and mitigation strategies.
- Develop and implement regulatory strategies to support the clinical development of Oncology therapeutic products, ensuring alignment with organizational objectives.
- Work closely within cross-functional teams, actively participating in decision-making processes related to drug development queries.
- Serve as a Regulatory Affairs representative on designated global project teams, offering strategic insights and guidance on key development and regulatory documents. Oversee the review process, ensuring scientific coherence and compliance with regional and global regulations.
- Engage with major health authorities to optimize regulatory strategies and maintain productive relationships.
- Organize preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.
- Keep abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.
- Drive opportunities for external engagement, contributing to relevant publications and participating in external speaking events to enhance the company's visibility and influence in the regulatory landscape.
Education, Qualifications, Skills, and Experience
Essential
- Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.
- Minimum of 2 years of experience in regulatory affairs or a closely related field.
- Expertise in therapeutic product regulations, with a thorough understanding of global regulatory frameworks.
- Understanding of regulatory affairs in Oncology throughout both early and late-stage development.
- Demonstrated competencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills.
- Strong abilities in communication, negotiation, and problem-solving.
- Proficiency in working effectively within cross-functional teams and managing multiple priorities.
- Excellent organizational and project management abilities, with keen attention to detail.
- Capacity to work autonomously while maintaining high-quality standards.
Desirable
- Ability to work strategically within innovative, complex, business critical and high-profile development programs.
- Prior experience with Oncology regulatory affairs; understand the strategic and tactical roles and deliverables of global regulatory strategy in Oncology drug development.
- Knowledgeable about regulatory co-development of IVDs/CDx with therapeutic products, with experience in engaging with major health authorities.
- Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As part of our team, you will work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are striving for technology adoption and automation to drive efficiencies and new innovations. Here we have the ability and autonomy to be an agent of change.
Next steps, if the role looks suitable to you, please apply!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.
An award-winning company
We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.
Inclusive environment
Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.
Work-life balance
Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.
Sustainability initiatives
We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.
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