Head of Regulatory Affairs & QA
Do you have expertise in, and passion for, Regulatory Affairs & QA? Would you like to apply your expertise to provide innovative medicines to patients in need in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
Business Area
With one of the largest pipelines, AstraZeneca Switzerland strives to build the best Regulatory Affairs team of the industry. Achieving timely marketing authorization is of utmost importance, with the aim to provide innovative medicines to patients in need.
What you will do
Provide strategic and operational regulatory leadership of the entire AZ portfolio to the local and global RA teams, to the local brand teams and also to the Swiss senior management. Act as a regulatory expert, responsible for the RA team to get the marketing authorization to launch new products, line extensions and/or new indications as soon as possible, and maintain existing registration licenses of the portfolio to ensure the license to operate. You will:
Be an active member of the Senior Leadership Team, contributing to setting the company’s strategic direction
Monitor and identify regulatory trends on local and global level, keeping contact with Swissmedic to improve the outcome of AZ projects
Be responsible for the management of the department, including performance, resource allocation, skill development, budget, pipeline planning, etc.
Be the GRP lead therefore responsible for ensuring the effective strategic and operational implementation of the QMS appropriate for Good Regulatory Practice.
Lead the Quality Assurance team to ensure the release of the product portfolio to the Swiss market and ensure GMP & GDP compliance
Essential for the role
Pharmaceutical or scientific degree
Significant experience in Regulatory Affairs
Deep knowledge of the legal and regulatory requirements in Switzerland and the regulatory environment
Strategic thinking, ability to define direction and set priorities
Excellent communication and negotiations skills
Written and spoken German & English
Good understanding of the QA function within the industry – ideally experience in Swiss market release
Knowledge of GMP/GDP guidelines of the European and Swiss pharmaceutical legislation
Experience in GxP compliance
Desirable for the role
Understanding of other health authorities such as EMA, FDA, Health Canada
French and/or Italian would be an advantage
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Interested? Apply today!
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 authorisation and employment eligibility verification requirements.
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