(Sr.) Manager, Regulatory Affairs-CMC (Gene Therapy)
AstraZeneca
- Beijing
- Permanent
- Full-time
- Contribute to develop and communicate CMC regulatory strategy, involved in analysing regulatory requirements, constraints and risk and changing trend, Identify, assess impact & proactively communicate changes to local regulations.
- Participate in developing change strategies for products in developing stage and lifecycle management protocols, involved in establishing effective networks with manufacturing sites and relevant technical functions
- Support with providing strategic, tactical and operational expertise and direction to China RA team, based on understanding of CMC regulations, Ensure project activities are delivered to a high standard and agreed time scales.
- Support to define the content required for CMC submissions with local RA team and global counterpart; Keep improving quality of CMC dossiers in CTA/NDA/variation submission
- Adherence to AZ code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs
- Bachelor degree or above in Pharmacy, Biology or related field.
- Have a proven track record from leading pharmaceutical companies.
- Fully understand the current regulatory practices and regulation related to CMC in China.
- Good networking with regulatory authorities.
- Strong collaboration across teams.
- 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.
- Good project management skill and experience.
- Minimum 2 years’ experience in below position in MNC as regulatory profession and qualified competence.
- Minimum 5 years working experiences in RA CMC or related roles.
- Working experiences in drug research & development/manufacturing & quality control/reviewing is an advantage.
- Experience in complex regulatory environment assessment.
- Experience in crisis management.
- Experience in drug/biologic manufacturing is a plus.
- China Pharmacist is plus.