Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety

This is a fully remote position, open to applicants in France.

📋 Description

• May act as a regional or local regulatory leader and primary contact both within the organization and with national authorities in EU countries as well as EMA.

• Independently or under the guidance of the GRL/Manager, contribute to the formulation of a global health authority interaction strategy in collaboration with GRT members.

• Responsible for developing, either alone or with support from the GRL/Manager, the engagement and interaction plans for health authorities pertaining to assigned products, which includes authoring, leading, and facilitating preparation meetings.

• Accountable for precise and comprehensive communication and interactions (including tracking in relevant systems) with health authorities, affiliates, and IMDD partners for the projects/products under their jurisdiction.

• Lead, either independently or with GRL guidance, a regulatory subteam to ensure that NDA/BLA/MAA/Extensions/Variations/Renewals submissions adhere to project timelines.

• Collaborate with the Project Manager to create the core global dossier and work with other members of the GRT as necessary.

• Ensure that regulatory submission timelines are in sync with program-level and corporate objectives.

• Contribute to the content and review of regulated documents.

• Assist in operational and compliance activities for assigned deliverables.

• Support inspections from health authorities related to GMP, GCP, and GPV.

• Responsible for providing updates on project and submission status to GRT members.

• Accountable for assisting the GRL with updates to the Affiliates and managing interactions with IMDD and partners.

⛳️ Requirements

• Experience in regulatory lifecycle management within Europe, especially with MRP/DCP and centralized procedures.

• Proficient in English.

• Exceptional attention to detail, including ensuring data consistency, traceability, and alignment across submission documents.

• Proactive problem-solving skills and the ability to work independently as well as collaboratively within a multidisciplinary team.

• Proficient in English.

• Experience with the FDA.

• Background in biological products.

🏝️ Benefits

• Comprehensive healthcare programs.

• Initiatives supporting work-life balance.

• Strong relocation support.

• Flexible working arrangements.

• Options for remote work.

• Tax assistance services available for international colleagues.