Sr. Manager/Associate Director, Regulatory Affairs (ONC)
AstraZeneca
- 北京市
- 长期
- 全职
- 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.
- Lead assigned regulatory activities based on the Strategy of China Regulatory Affairs to achieve RA goals.
- Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.
- Bachelor degree or above in Pharmacy, Medical, Biology or related field
- Have a proven track record on performance and reputation from leading pharmaceutical companies.
- 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.
- Minimum 2years’ experience in below positions.
- Minimum 12 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.
- Experience in drug/biologic manufacturing is a plus.
- China Pharmacist/Physician License is plus.