Regulatory Affairs Specialist/ Junior RAS

at  AstraZeneca

ESSENTIAL REQUIREMENTS:

• regulatory experience in the pharmaceutical industry
• Master of Science in Pharmacy or other relevant biomedical/scientific background
• English written & spoken (very good)
• Working knowledge of the EU and local regulatory legislation guidelines relevant to role
• Strong personal integrity, customer and quality focus
• Ability to organize, prioritize and work effectively in a constantly evolving environment and with multiple priorities

ABOUT A ROLE

As a part of AstraZeneca, You will be responsible to ensure licence to operate for our innovative products, perform regulatory activities for defined part of AstraZeneca portfolio and drive projects related with among others Regulatory Excellence and quality assurance. The position is an office-based role within Medical Department, that works closely and share knowledge with both global AstraZeneca teams and locally within cross-functional teams with individuals from Medical, Distribution/Supply chain, Market Access and Marketing departments.

MAIN DUTIES & RESPONSIBILITIES:

• Ensure Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA), line extensions and life cycle submissions/ maintenance.
• Coordinate translation proces and quality check for Product info for CP, MRP/DCP and nationally approved products
• Support local packs preparation & pack changes implementation to ensure labelling compliance
• Authoring and management of local part of Regulatory dossier and product knowledge according to AZ processes.
• Cooperate with cross functional teams to ensure regulatory contribution to product launches
• Monitor status of ongoing regulatory processes for assigned products and ensure outcome from Regulatory Authority is received on time
• Work closely and swiftly with local and global cross functional teams (Distribution/ Medical/ Commercial/Market Access, Marketing)