Senior Regulatory Affairs Director - Oncology

AstraZeneca • Boston, MA

1d • Hybrid

About The Position

AstraZeneca is seeking a strategically focused Senior Regulatory Affairs Director (SRAD) to play an integral part in bringing life-changing Oncology medicines to patients. Within Oncology Regulatory Science and Strategy (ORSS), the company works in areas of unmet need, employing innovative regulatory approaches to deliver life-changing treatments efficiently and effectively. The SRAD will serve as the Franchise Global Regulatory Lead (GRL), responsible for developing and implementing global strategies for complex oncology programs with multiple indications. This role may also function as a regional lead based on location. The SRAD is expected to establish external relationships with key stakeholders to maintain a competitive advantage and will be recognized as a senior leader within the Regulatory community.

Requirements

• An advanced degree in a science related field and/or other appropriate knowledge/experience.
• 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.
• Previous experience in leading major health authority interactions.
• Solid knowledge of regulatory affairs within several therapeutic areas in early and late development.
• 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.
• Proven leadership experience.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• 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.

Nice To Haves

• Experience in the development or application of radio-conjugates would be highly advantageous.
• Previous experience with FDA advisory committee and EMA oral explanation hearings would be a plus
• Previous experience working on due diligence activities and in a business alliance environment.
• Ability to work strategically within a complex, business critical and high-profile development program.

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.

Benefits

• Competitive salary and benefits package on offer
• Individualized flexibility in ways of working
• Ability to balance personal and work commitments
• Strong culture of collaboration and teamwork
• Engaging face-to-face in our offices 3 days a week
• Annual base salary for this position ranges from $211,581.60 - 317,372.40
• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program (salaried roles)
• Eligibility to receive a retirement contribution (hourly roles)
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Empowered to push the boundaries of science and unleash your entrepreneurial spirit
• Opportunity to make a difference to medicine, patients and society
• Inclusive culture that champions diversity and collaboration
• Commitment to lifelong learning, growth and development
• Opportunity to pioneer the future of healthcare
• Inclusive and equitable environment where people belong
• Power of diversity to push the boundaries of science
• Help you realise the full breadth of your potential

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees