Regulatory Affairs Associate

Main Responsibilities :

• Support regulatory activities (New MAAs, line extensions, renewals, CMC changes, Safety Label Changes) in Rest of World countries, by ensuring timely and accurate availability of business critical documents, not provided as part of the core dossier
• Manage and coordinate process for Apostille or legalization of business critical documents required to support regulatory activities in Rest of World countries
• Manage relationship to external vendors providing legalization and notary services – act as Single Point of Contact with these vendors
• Manage and coordinate process for Letters of Authorization, required by Health Authorities to support regulatory activities in Rest of World countries
• Coordinate and facilitate timely delivery of business critical documents to CPOs worldwide
• Manage tracking of all legalization and dispatch activities, ensuring accurate and timely oversight available to relevant business partners
• Provide operational support to RA Regions, e.g. maintaining generic mailbox, maintaining archive, organizing meeting support, coordination of signatures
• Provide training on declaration letters and legalization process to RA Regions and key stakeholders as needed
• Provide additional operational support to RA MOW, as required

Qualifications and Experience :