(Sr.) Manager, Regulatory Affairs (Rare Disease)
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
- 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.
Education, Qualifications, Skills and Experience
Essential
Academic / Professional Qualification
- Bachelor degree or above in Pharmacy, Medical, Biology or related field.
Technical / Skills Training
- 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.
Working Experience
- Minimum 2 years experience in below position.
- Minimum 6 years working experience in regulatory affairs of MNC.
Desirable
- Experience in drug/biologic manufacturing is a plus.
- China Pharmacist/Physician License is plus.
【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. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】
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.
