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
Are you a strategically focussed Regulatory CMC professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on!
About AstraZeneca
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 impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
The Regulatory Affairs CMC Director will provide appropriate CMC Regulatory Strategy, Operational, tactical, and decision-makingexpertise for projects and complex product ranges from development phase through to global launch and post approval lifecycle management.
This role will represent CMC in networks across the business including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, Global Quality and Operations. The role holder may lead development of new guidance, policy, and processes. They
will also be a key partner for identified customer functions to facilitate high quality partnerships within and external to AstraZeneca. The role will support and coach across CMCRA forproducts/projects and /or specialist areas. The Regulatory Affairs Director will have an in depth understanding in the complexity and challenges that are required for Dossier submissions and have proven project management skills.
What you’ll do
Provide CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.
Provide strategic CMC RA expertiseand direction for CMC submissions across the lifecycle of a product.
Where necessary lead CMC related interactions with Health Authorities globally.
Accountable for the provision of expert regulatory strategic guidance in support of Operational initiatives, for example complex/accelerated projects and/or post approval changes.
Contribute to or lead policy setting and strategy development in the CMC RA environmentwithin or external to AstraZeneca.
Lead knowledge sharing and provide coaching both within CMC RA and wider business functions.
Share knowledge, leading/contributingto Community of Practises across the groups or within a business unit.
Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC.
Support the implementation of agile and novel approaches in CMC Dossier Management that drive new ways of thinking to enhance efficiency and flexibility.
Participate and /or lead due diligence teams as necessary.
Lead /contribute to cross therapeuticnon-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / ensure management of regulatory information and ensure regulatory compliance on behalf of AZ.
Highlight resource needs for product as appropriate for effective planning purposes.
Education, Qualifications, Skills and Experience
Essential for the role:
Bachelors degree in Science, Regulatory Sciences or Pharmacy.
Breadth of knowledge of manufacturing, project, technical and regulatory project management.
Strong understanding of regulatory affairs globally
Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products
Stakeholder & Project management
Desirable for the role:
Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
Business, financial and supply chain understanding/ awareness
Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
Experience in developing products to be administered by the respiratory route.
Experience in Line and/or matrix leadership
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.
Where can I find out more?
Our Social Media,
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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.
We’ll keep you up to date
