(Sr.) Manager, Regulatory Affairs (Onco)
Senior RA manager is responsible for managing multiple brands/compounds, to obtain regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group; support TA head to develop a highly reliable and professional profile and process for AZ China, to supervise and coach junior staff to execute the regulatory activity and achieve the business objectives.
Typical Accountabilities
- Assist RA TA head to set strategic regulatory direction for China portfolio. to achieve in-time and high-quality approval and facilitate full speed launch, and lead the execution of submission/approval as well as the HA communication.
- Develop and implement options to deal with changes in timelines and priorities through the comprehensive assessment of various influential factors. 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, proactively working on policy interpretation and policy advocacy.
- Lead the stakeholder management and be good at the complexity management.
- Supervise, coach, support junior staff, to encourages the sharing of best practices, take decision and accountability for actions; challenge status quo for continuous improvement, help build an open and trusting atmosphere.
- Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPsand other required SOPs.
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 from a major pharmaceutical company.
- Fully understand the current regulatory practices and regulation in China.
- Good networking with regulatory authorities.
- Strong ability on building trustful relationship among peers and junior staff.
- Strong collaboration across teams.
- Excellent 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 positions.
- Minimum 10 years working experience in Regulatory Affairs of MNC.
- Experience in handling complex regulatory projects, various kinds of regulatory submissions/approvals.
- Experience in complex regulatory environment assessment.
- Experience in crisis management.
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.
