Director EU Regulatory Strategy

4 days ago


United Kingdom Planet Pharma Full time

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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