Regulatory Affairs Associate/ Senior Regulatory Affairs Associate
AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare.
Here we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
We believe in the potential of our people and you will develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
As a Regulatory Affairs Associate/ Senior Regulatory Affairs Associate at AstraZeneca, you will play a pivotal role in delivering life-changing medicines to patients and change their lives.
Main Duties and Responsibilities:
Your job responsibilities will be, but not limited to:
Implement regulatory strategies to achieve rapid and high quality approvals
Ensure high standard of regulatory compliance
Maintain licenses (both product and clinical trial) through timely renewal and life cycle management in order to support the company’s business objectives
Responsible for both Hong Kong and Macau regulatory affairs, quality assurance and patient safety
Implement Quality Management System (QMS) and the related GxP activities accordingly
University graduate and above in Science or Pharmaceutical related field
Min. 2-year experience in a major international/local pharmaceutical company
Possess a high degree of honesty with proven track record built on success stories and sound ethics from pharmaceutical company
Good knowledge on current local applicable laws & regulations, regulatory practices and industry codes in both Hong Kong and Macau
Excellent in both written and spoken English and Chinese
Relevant pharmaceutical regulatory affairs experience
Possess Hong Kong Registered Pharmacist License
Sound computer skills on Microsoft Office and Adobe Illustrator
Candidate with more experiences will be considered for senior position
We offer attractive remuneration & benefit package and excellent opportunity for your career development.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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.