R&D - GRA - Regulatory Affairs Manager - BJ
Core
Develop and implement regulatory strategies for I&I Alliance products in China, leading cross-functional teams to ensure timely submission and delivery of Marketing Authorizations.
Role type
Senior IC Regulatory Affairs Manager
Builds
Marketing Authorizations and lifecycle management for I&I Alliance products in China
Domain
Pharmaceuticals, China regulatory landscape
Deliverable
client delivery
Required skills
China regulatory submissions, NMPA requirements, global regulatory frameworks, cross-functional coordination, project management, dossier quality management, regulatory strategy development, risk evaluation, stakeholder communication
Preferred skills
Master's degree in Pharmacy, Medicine, or Life Sciences
Technologies
N/A
Responsibilities
Support development and implementation of regulatory strategies for I&I Alliance products in China; Lead cross-functional teams to ensure timely submission and delivery of Marketing Authorizations; Manage regulatory processes effectively and in compliance with internal standards and regulatory requirements; Establish effective coordination of regulatory activities in China; Work across project teams to evaluate regulatory pathways, risks, and timelines; Monitor and adopt new regulatory requirements and Group standards; Communicate regulatory environment changes to relevant stakeholders.
Seniority
Senior, hands-on IC
