Position: Regulatory Affairs Associate - Fixed Term Contract - 12 months
Location: Dublin
Competitive Salary & Excellent Company Benefits
Closing Date: 21st April 2023
Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise to make a difference to the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
Business Area
It's our patients that come first, every decision we make and action we take is centred around how we can better serve them. It's why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world.
What you will do:
As the Regulatory Affairs Specialist, you will:
- Support in the delivery and maintenance of competitive licences for Ireland/Malta
- Ensure regulatory compliance for defined product and project responsibilities.
- Prepare high quality regulatory applications and regulatory responses for Ireland/Malta
- Ensure timely submission and approvals of licence applications and maintenance activities and timely tracking of these activities.
- Support with clinical trial applications, ensuring compliance with Clinical Trial Regulation
- Keep up-to-date with developments in the external regulatory environment and share this knowledge across the department and beyond, in the business interest.
- Provide regulatory support to the local business as required, including competitor intelligence, preparation of Abbreviated Prescribing Information etc.
What you will bring:
Essential
- Life Sciences Degree or appropriate professional qualifications
- Operational regulatory experience in the pharmaceutical industry in Ireland
- Commercial awareness
- Good written and verbal communication skills
- Good attention to detail
Desirable
- Post-graduate qualification
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 ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours. Please apply by submitting your CV.
