Director - EU Regulatory Strategy
June 21
🏡 Remote – Anywhere in California
Description
• The Director/Senior Director, EU Regulatory Strategy, reporting to the Head of Regulatory, is responsible for the development and implementation of the EU regulatory strategy and plan for assigned clinical and/or pipeline programs. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions.
Requirements
• Education in life sciences required • 7+ years of 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 but not required • 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%)
Benefits
• 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., MAA module 1, briefing documents, DSUR) • Lead response to EU CTR questions to support clinical trials in EU5 • Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success • Identify regulatory risks and opportunities and work with key stakeholders to develop solutions • Provide regulatory input and support for business development activities • Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable • Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., PRC, program teams, clinical development teams, study teams) • 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 • Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed
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