May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA.
Contribute (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members
Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings
Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit
Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines
Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate
Ensure regulatory submission timelines are aligned with program level and company objectives
Contribute to content and reviews for regulated documents
Support operational and compliance activities for assigned deliverables
Support GMP, GCP, and GPV inspections from health authorities
Accountable to provide updates on project and submissions status to GRT members
Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners

Experience in regulatory lifecycle management in Europe, particularly with MRP/DCP and centralized procedures.
Fluent English
Excellent attention to detail, including data consistency, traceability, and alignment across submission documents
Ability to solve problems proactively and problem solving skills and the ability to work both independently and collaboratively in multidisciplinary team
Fluent English
Experience with FDA
Experience with biological products

Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety

Key skills