China Job Openings
AstraZeneca
(Associate) Manager, Regulatory Affairs (Onco)
October 15, 2024
地点 北京, 北京, 中国
职位 ID R-210511
发布日期 10/15/2024
职位 ID R-210511
发布日期 10/15/2024
申请
Manager, Regulatory Affairs as an individual contributor, is responsible for developing regulatory strategy for the responsible projects with the guidance of senior regulatory manager; responsible for the regulatory strategy implementation by CTA/NDA submission/approval; responsible for HA interaction for regulatory strategy assessment with the guidance of senior regulatory manager; support line manager for regulatory intelligence collection and analysis, and manage on integration for regulatory strategy assessment.
Typical Accountabilities
Essential
Academic / Professional Qualification
Astra Zeneca 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.
Typical Accountabilities
- Develop and implement regulatory strategies for allocated portfio, to achieve in-time and high-quality approval and facilitate full speed launch.
- Maintain product licenses in assigned portfolio through timely lifecycle management with a high standard.
- Maintain the awareness of market intelligence and shape the regulatory environment relevant to the assigned portfolio.
- Actively maintain and develop excellent relationship with local regulatory authorities and external stakeholders.
- Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs, to drive issue management.
Essential
Academic / Professional Qualification
- Bachelor degree or above in Pharmacy, Medical, Biology or related field.
- Have a proven track record on performance and reputation from leading pharmaceutical companies R&D team.
- Fully understand the current regulatory practices and regulation in China.
- Good networking with regulatory authorities.
- Strong collaboration across teams.
- Good project management skill and experience.
- Excellent verbal and written communication skills and fluent in both oral and written English.
- Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.
- Minimum 2 years experience in below position.
- Minimum 6 years working experience in regulatory affairs of MNC.
- Experience in drug/biologic manufacturing is a plus.
- China Pharmacist/Physician License is plus.
Astra Zeneca 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.
申请
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