Senior Regulatory Affairs Director - Oncology

Role Summary

The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL), developing and implementing the global strategy on complex oncology programs with multiple indications. In addition, the SRAD has the ability to function in dual capacity by serving as the regional lead based on location. The SRAD establishes external relationships with key stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the Regulatory community.

Responsibilities

• Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team.
• Ensure that the strategy is crafted to deliver approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
• Lead the assessment of emerging data against aspirations and update Leadership on project risks/mitigation activities.
• Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic advice and accountable for all regulatory activities.
• Own the delivery of all milestones on your team including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations.
• Demonstrate strategic leadership skills thereby contributing to effective product development.
• Promote novel regulatory initiatives internally and engage externally on the corresponding topics. Lead the development of novel tools and technology.
• Partner and influence developing views/guidance on a global scale.

Qualifications

• Required: Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired.
• Required: Previous experience in leading major health authority interactions.
• Required: Solid knowledge of regulatory affairs within several therapeutic areas in early and late development.
• Preferred: Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
• Required: Proven leadership experience.
• Required: Ability to think strategically and critically and evaluate risks to regulatory activities.
• Required: Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Preferred: Experience in the development or application of radio-conjugates would be highly advantageous.
• Preferred: Previous experience with FDA advisory committee and EMA oral explanation hearings would be a plus
• Preferred: Previous experience working on due diligence activities and in a business alliance environment.
• Preferred: Ability to work strategically within a complex, business critical and high-profile development program.

Education

• An advanced degree in a science related field and/or other appropriate knowledge/experience.