Regulatory Affairs Lead, Oncology (Sr. Manager)

Join Our Team at Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope :

• Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and / or products with considerable technical complexity and diversity requiring impact on internal decision making.
• Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted problem solving and internal decision making.
• Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products.
• Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; influences internally and externally to contribute to project / product decision making ensuring viable regulatory approaches and interacts with regulatory agencies.
• Accountable for project-related and marketed product-related communications and interactions with project and / or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects / products reflect up-to-date regulatory strategies.
• May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project / product objectives for global and / or regional products. Advises project / product teams in the application of regulatory strategies and solving of regulatory issues.
• Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products.

Responsibilities and Accountabilities :

Regulatory Excellence

Organization & People Management