Senior Director, European Regulatory Strategy Lead

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

📋 Description

• Act as the European Regulatory Lead for cleminorexton and other designated development programs.

• Formulate and implement regulatory strategies throughout the European Union, United Kingdom, Switzerland, and other relevant regions.

• Oversee the planning, preparation, and submission of Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), pediatric regulatory submissions, briefing documents, and other regulatory filings.

• Represent the organization in meetings and communications with the European Medicines Agency (EMA), EU National Competent Authorities, the Medicines and Healthcare products Regulatory Agency (MHRA), Swissmedic, and other health authorities.

• Provide EU regulatory guidance and strategic insights to cross-functional program teams.

• Lead pediatric development and submission activities outside the US.

• Ensure adherence to European and international regulatory standards and guidelines.

• Relay regulatory developments and their implications to stakeholders.

• Collaborate with Regulatory Affairs leadership to enhance capabilities and operational excellence.

• Identify, engage, and manage external EU regulatory consultants and vendors.

• Work alongside global regulatory colleagues to synchronize European and other regional strategies.

⛳️ Requirements

• Bachelor’s degree in a scientific field.

• Over 12 years of advancing regulatory affairs experience in the pharmaceutical or biotechnology sector.

• At least 5 years in a regulatory leadership position with substantial European exposure.

• Extensive experience in leading European regulatory strategies and submissions.

• Significant expertise in EU pediatric regulatory strategies and submissions.

• Recent, relevant experience with EU regulatory submission strategies, structures, and content, including MAAs, CTAs, pediatric submissions, briefing documents, and other European regulatory filings.

• Successful regulatory engagements with the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other pertinent health authorities.

• Previous experience acting as the European Regulatory Lead for development and registration programs within a matrixed setting.

• In-depth knowledge of nonclinical and clinical drug development, ICH, EMA, EU regulatory requirements, EU National Competent Authorities, MHRA, Swissmedic, and other applicable international regulatory guidelines.

• Strong background in leading cross-functional teams and providing strategic regulatory guidance from early development through registration and lifecycle management.

• Exceptional written, verbal, presentation, and influencing abilities.

• Proven skills in analytical thinking, problem-solving, organization, negotiation, and decision-making.

• Capacity to excel in a dynamic, innovative environment.

• An advanced degree (PhD, PharmD, MS, or JD) and experience in small molecule development is highly preferred.

• Experience in CNS is strongly preferred.

• Familiarity with regulatory submissions and health authority interactions in Japan and/or China is advantageous.

• Experience working with a US-based Global Regulatory team and cross-functional partners.

🏝️ Benefits

• Occasional travel, including trips to the US.

• Equal opportunity and disability accommodation support throughout the application process.