Planet Pharma is pleased to be recruiting for a temporary Director EU Regulatory Strategy to work on an initial 6 months basis fully remote in the UK. It is imperative you can Lead an MAA and hold proven experience in the EU. Position Responsibilities: · Serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success · Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements · Lead MAA review, including response to List of Issues and EU-SmPC negotiations · Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan · Serve as point of contact with EMA leading and managing regulatory interactions, building trusted relationships with regulatory authorities · Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA) · Identify regulatory risks and opportunities and work with key stakeholders to develop solutions · Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance · Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance · Provide support to local regulatory experts in Rest of World to support applications and reviews. · Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed Requirements: · Education in life sciences required · Proven experience in biopharmaceutical industry with deep understanding of EU regulatory requirements · Demonstrated experience of leading successful engagement with EMA · Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred. · Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills · Strong written, verbal communication skills, and interpersonal skills · Capable of managing shifting priorities in a rapidly changing and environment · Ability to travel domestically and internationally (10%)