Executive Director, Regulatory Science Communications

Executive Director Regulatory Science Communications

The Executive Director Regulatory Science Communications is responsible for the functional areas of Scientific / Regulatory Writing, Regulatory Editing, and Regulatory Document Quality Control to ensure the timely preparation and submission of critical regulatory documents such as IND / CTA, NDA / BLA / MAA, regulatory responses, briefing documents, clinical protocols, clinical study reports, investigator brochures, and others across all stages of development.

Essential Duties And Responsibilities :

• Provides expert leadership for each functional area to ensure the timely preparation, completion, and submission of critical regulatory documents.
• Builds and maintains an effective team by recruiting and hiring appropriate personnel to execute tasks related to regulatory document development, publishing, and submission.
• Oversees teams to organize, manage, and execute tasks related to the development of documents, ensuring that timelines and quality standards are met.
• Helps teams negotiate timelines with key stakeholders for documents intended for regulatory submission.
• Oversees the identification, hiring, and managing of consultants for peak workload and specialized projects.
• Actively manages departmental resources and budget to meet strategic goals.
• Oversees development of standards, procedures, and optimized processes for regulatory document development.
• Reviews and contributes to content development and critically assesses, interprets, and summarizes data to produce high-quality communications.
• Ensures consistency in documents within and across programs by overseeing the management of messages and developing and maintaining document standards, models, and templates.
• Oversees the development of appropriate SOPs and work instructions for each functional area within the Regulatory Science Communications group.
• Identifies continuous improvement opportunities and acts to improve processes.
• Other duties as needed.

Supervisory Responsibilities :

Education / Experience / Knowledge & Skills :

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Experience / The Ideal For Successful Entry Into Job :

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Work Environment / Physical Demands :

Our office is a modern, open-plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.