Specialist, Regulatory Affairs (Fresh Graduate in 2022)
- Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.
- Implement regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch.
- Maintain product licenses through timely renewal to high standard
- Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
- Under supervision: establish relationship with local regulatory authorities.
- Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
- Actively participate in team working and share best practice examples & learning with the team and regional/global colleagues
- Bachelor or above in Pharmacy, Medical, Biology or related field
- Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
- Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
- Project management primary level skill
- Chinese and English (proficiency level)
- Computer skill: word, excel, power point
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.