Global Regulatory Affairs Director

The Director of Global Regulatory Affairs will lead the development and execution of US and Global regulatory strategies from preclinical activities through post approval. This role requires careful understanding of current Regulatory environment (competitive intelligence and Health Authority guidance).  Must be able to partner with the Project Team members to ensure successful execution of regulatory submissions, and be able to provide timely interactions with global Health Authorities to obtain agreement on the innovative strategies proposed to support getting products to the clinic and to market expeditiously.

The Director of Global Regulatory Affairs will foster vaccine development by facilitating the identification and resolution of scientific and regulatory issues with global Health Authorities such as the US FDA, EMA (Europe), CDSCO (India) and iccdr,b (Bangladesh).

The Director will lead the creation of global regulatory strategies for their products, lead the preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs, lead the creation of responses to Healthy Authority requests for information, and interact directly with global Health Authorities.

• Assume Global Regulatory Lead responsibilities for assigned programs.
• Function as primary contact with Health Authorities.
• Lead the planning, execution, and assessment of product life cycle management activities from early development through post approval
• Proactively formulate regulatory strategies that provide for streamlined development and approval timelines, while accurately interpreting and reflecting regulatory guidelines
• Collaborate closely with all other departments (nonclinical, CMC, immunology, development, clinical, and project management) on the development and implementation of the regulatory strategy for each program
• Lead and coordinate all regulatory activities required for submissions to Health Authorities for assigned products, including the planning, preparation for, and conduct of meetings with Health Authorities.
• Initiate and respond to Health Authority contacts to ensure expedient and efficient review and approval of products
• Lead the creation of all documents submitted to Health Authorities, ensuring they are strategic, complete, well-organized, scientifically accurate, of high quality, and are in regulatory compliance as well as presented in a way that facilitates Health Authority review
• Identify, monitor, and resolve regulatory issues and report progress to Management and Senior Leadership
• May include approximately 10% travel depending on business needs (post-COVID)