Director Global Regulatory Oncology Pfizer La Jolla

Job Description: • 2-minute read •
*Serve as Global Regulatory Lead on multifunctional project teams in the oncology therapeutic area, providing regulatory expertise to teams. Activities may also involve regional focus for US or EU.
*Develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages.

*Manage all regulatory aspects of projects, including the preparation and submission of correspondences and applications to regulatory agencies.
*Act as direct liaison with FDA, EMA and other Health Authorities to facilitate the prompt review and approval of applications.
*Understand regulatory environment and communicate priorities to stakeholders.

Responsibilities
*Accountable for leading the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects.
*Partner with project teams and other customers (e.g., Oncology Research Unit/Pfizer Oncology, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, CTAs, BLAs/NDAs, MAAs, sNDAs, etc.) meet business needs and are provided within agreed time, cost and quality standards.
*Develop and maintain constructive working relationship with Health Authority contacts.
*Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated.
*Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
*Ensure business compliance, and implementation of and adherence to regulatory standards.

Qualifications
*BS; higher degree advantageous with 10+ years of relevant experience
*Prior oncology drug development experience preferred. Immuno-oncology experience beneficial.
*Proven examples of delivery with demonstrable contribution in global Regulatory activities, including knowledge of IND/CTA, BLA/NDA/MAA and other submission processes.
*Proven ability to manage complex regulatory issues.
*Proven ability to consistently deliver within time, cost and quality standards.

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