Director EU Regulatory Strategy
4 days ago
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%)
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