Senior Director Regulatory Affairs

Responsibilities:

• Develop and implement regulatory strategies for early and late-stage assets, actively contributing to the formulation of clinical plans.
• Provide vital regulatory guidance to internal teams, external CROs, and consultants throughout the planning, organization, and submission phases of regulatory dossiers to entities such as the European Medicines Agency (EMA), European National Regulatory Authorities (NRAs), and other global regulatory bodies.
• Interpret current regulatory requirements to devise practical submission strategies for both European and global markets.
• Collaborate with CROs to prepare clinical submission materials tailored for regions such as Latin America and Asia.
• Monitor and evaluate changes in regulatory requirements and guidelines, adjusting development strategies for company assets accordingly.

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Experience:

• Possess a bachelor’s degree in a relevant scientific field, with an advanced degree being advantageous.
• Accumulate at least 7 years of regulatory experience within the pharmaceutical/biologics industry, demonstrating progressive responsibility and expertise.
• Previous involvement in vaccine development is preferred. Proficient in US, EU, and international regulatory standards and GxP guidelines pertinent to vaccine development and approval.
• Direct experience in leading and preparing for regulatory agency meetings. Comprehensive understanding of clinical trial designs and global reporting requirements.
• Demonstrated ability to develop clinical and labeling content for original and supplemental license applications.
• Strong interpersonal skills to foster positive relationships internally and externally, including with regulatory authorities, vendors, investigators, and other stakeholders.