AstraZeneca seeks a Senior Regulatory Affairs Specialist for its Regional Centre of Excellence to manage operational delivery of product life-cycle management activities across assigned markets. The role involves dossier preparation, regulatory authority coordination, and post-approval implementation while collaborating with cross-functional international teams.
Responsibilities
Plan and execute life-cycle management activities aligned with market plans and general procedures
Compile and customize regulatory dossiers including country-specific modules and administrative documents
Coordinate with international regulatory and CMC teams to ensure timely document availability
Monitor regulatory authority evaluation milestones and coordinate comprehensive, timely responses
Track approvals and implement post-approval variations, renewals, and safety updates
Requirements




University degree in Pharmacy, Sciences, Chemistry, Biology, Engineering, or related discipline
4+ years relevant biopharmaceutical regulatory affairs experience with dossier preparation
Strong knowledge of post-approval submissions, local administrative requirements, and regulatory authority interactions
Proficiency in English and ability to operate in multicultural, matrix environments
Project coordination skills with attention to detail and stakeholder management capabilities
Experience with CMC and non-CMC content collaboration across international teams
Veeva RIM/ERV or comparable regulatory management systems experience (desirable)

📌 Senior Regulatory Affairs Specialist Coe (Xico)
🏢 Astrazeneca
📍 Xico