Associate Regulatory Affairs Strategy Director (Oncology)

Essential Duties and Responsibilities

• Interact directly with regulatory authorities.
• Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
• Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
• Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
• Coordinate, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
• Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Lead multiple assets and/or studies as assigned.
• Liaise internally with members of Exelixis' functional departments.
• Liaise externally with vendors, licensors, consultants, and joint development collaborators.

Supervisory Responsibilities

None

Education/Experience

• Bachelor's degree in related discipline and a minimum of eleven years of related experience; or,
• Master's degree in related discipline and a minimum of nine years of related experience; or,
• PhD degree in related discipline and a minimum of five years of related experience; or,
• Equivalent combination of education and experience.

Knowledge/Skills

• Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.
• Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
• Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
• Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.
• Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
• Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

Job Complexity

• Capable of managing the execution of multiple tasks.
• Ensures appropriate prioritization and execution for area of responsibility.
• Proactively anticipates, prioritizes and resolves task-related challenges.
• Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.

Working Conditions

Travel approximately 10%