AstraZeneca seeks a Regulatory Affairs Manager II to lead end-to-end planning and execution of global regulatory deliverables for established pharmaceutical products. The role manages moderate to complex submissions, labeling maintenance, and cross-functional coordination across regions as an individual contributor within a global regulatory team.
Responsibilities
Lead planning, coordination, and execution of global regulatory submissions and maintenance activities
Provide regulatory expertise on submission strategy, labeling requirements, and procedural documentation across regions
Develop and maintain submission delivery and content plans using digital tools like Veeva Vault
Identify regulatory risks, propose mitigations, and provide proactive stakeholder updates
Mentor regulatory team members and contribute to process improvement initiatives
Requirements
Bachelor's degree in science or related discipline
Minimum 8+ years of biopharmaceutical regulatory experience including maintenance and labeling
Thorough knowledge of regulatory product maintenance processes
Strong project management and multi-disciplinary team leadership skills
Excellent English communication and scientific knowledge
Proficiency with project management and document management tools
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