Senior Regulatory Affairs Director

About the role

As the Senior Regulatory Affairs Director at AstraZeneca, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. You will lead the development and implementation of the global regulatory strategy for a product or group of products of increasing complexity, ensuring rapid approval with advantageous labeling aligned with product properties and the needs of the business, markets, and patients.

R&D Oncology drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring global patient access.

Responsibilities

• Develop and implement the global regulatory strategy for high-profile, complex, or novel development programs.
• Ensure the regulatory strategy delivers rapid approval with advantageous labeling.
• Demonstrate strategic leadership and deep understanding of global regulatory science and drug/biologic development processes.
• Lead the planning and construction of the global dossier and core prescribing information.
• Conduct regulatory risk planning and mitigation.
• Lead the Global Regulatory Sub-team (GRST) with key members from regional, emerging markets, RA CMC, and delivery & enablement perspectives.
• Accountable for delivering all regulatory milestones, including assessing the probability of regulatory success and implementing risk mitigation measures.
• Oversee product maintenance, supply, and compliance activities for marketed brands.
• Objectively assess emerging data against aspirations and update senior management on project risks and mitigation activities.
• Partner with marketing company and regional regulatory affairs staff to influence developing views and guidance.
• Provide leadership, coaching, and performance feedback to regulatory staff; participate in skill development and recruitment.
• May lead regulatory operational activities, including submission planning, Health Authority interactions, and providing regulatory expertise on procedural and documentation requirements.

Requirements

• Bachelor’s degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 10+ years of experience in overall drug/biologic development processes and strategies for high-profile, complex, or novel development programs.
• Deep understanding of global regulatory science and its integration with program strategy.
• Broad experience working in the pharmaceutical business and prior experience in multiple areas within regulatory affairs.
• Proven experience leading regulatory and cross-functional teams, as well as stakeholder management.
• Successful leadership of at least one global regulatory marketing approval as Global Regulatory Lead (GRL) across major regions (US and EU), including leading response teams and labeling negotiations.
• Ability to think strategically, critically evaluate risks, and adapt to regulatory activities.
• Previous experience leading major Health Authority interactions.
• Excellent oral, written, and presentation skills.
• Strong organizational skills and ability to work in a fast-paced, hands-on environment.
• Flexible, proactive, and able to manage multiple projects while adapting to changing business needs.

Preferred Qualifications

• Master’s or PhD in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• Experience in the development or application of radio-conjugates (highly advantageous).
• Experience with FDA advisory committees and CHMP oral explanations.
• Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through coaching or mentorship.
• Contribution to non-project business initiatives (e.g., portfolio or cross-functional level).
• Experience in Oncology (small molecules and biologics) is preferred.

Benefits

At AstraZeneca, we champion an inclusive culture that celebrates diversity and collaboration, and we are committed to lifelong learning, growth, and development. Our positions offer:

• A short-term incentive bonus opportunity.
• Eligibility to participate in our equity-based long-term incentive program (for salaried roles).
• Retirement contribution (for hourly roles).
• Qualified retirement program (401(k) plan).
• Paid vacation, holidays, and leaves.
• Health benefits, including medical, prescription drug, dental, and vision coverage.

Pay

The annual base pay for this position ranges from $218,058.40 to $327,087.60 USD. Hourly and salaried non-exempt employees will also receive overtime pay for qualifying hours. Base pay may vary depending on market location, job-related knowledge, skills, and experience.