Regulatory Affairs Lead Oncology Associate Director

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

This position plays a key role in the regulatory affairs department. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing regulatory strategies.

Responsibilities and Accountabilities:

• Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams.
• Provides regulatory expertise for New Product Planning and Licensing due diligence activities.
• Member of important project teams/task forces requiring the interpretation of applicable FDA/ICH regulations to ensure compliance.
• Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions.
• Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs.
• Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances.
• Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies.
• Interacts with FDA and global health authorities on project related communications, including facilitating Divisional and committee meetings such as Pre-IND, IND, Pre-NDA, and NDA meetings. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries.
• Assists with ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines.