Regulatory Affairs Specialist - HCM

About this role

Typical Accountabilities: Maintain in-depth knowledge of key product-related areas, including commercial strategy, dossier content, regulatory intelligence, regulatory timelines, and supply strategy. Develop and implement milestone plans for drug registrations. Prepare high-quality regulatory submissions and manage product registrations for new applications, license extensions, and variations

Develop packaging artwork to support new product launches and lifecycle management. Provide detailed updates on the regulatory status of impacted products and advise on appropriate regulatory pathways and processes. Maintain regulatory compliance databases and associated processes

Monitor registration activities to ensure timely submission and approval of new product registrations, license extensions, and regulatory changes, aligned with company strategic business goals. Review promotional materials to ensure compliance with local regulations. Manage submissions and approvals for GMP site registrations in a timely manner

Prepare high-quality regulatory documentation and respond promptly to DAV and hospital queries to support tender processes. Manage regulatory matters related to stock issues efficiently and coordinate with relevant cross-functional teams to help prevent stock shortages. Provide regulatory input and comments on draft regulations

Typical People Management Responsibility (direct / indirect reports): • Approximate number of people managed in total (all levels) - 1-3• Matrix Manager – (projects/dotted line)• Manager of a team • Grandfather (manager of a manager) What is the global remit? (how many countries will the role operate in?): • Own country Education, Qualifications, Skills and Experience: Essential: University Degree in Pharmacy. Good command in English skills. Knowledge of Pharmaceutical products development process and have strong knowledge and understanding of local regulatory requirements and processes

Proactive and highly committed to support and

Apply for this role on AstraZeneca’s official careers site.