Regulatory Affairs Director
Location: Gaithersburg, Maryland, USA
Job ID: R-237818
Date Posted: 22 Oct 2025
Closing Date: 29 Nov 2025
About AstraZeneca
AstraZeneca is committed to developing life-changing medicines with scientific integrity and strong ethical standards. Within the Oncology Regulatory Science Strategy and Excellence (ORSSE) team, the company drives innovation, strengthens partnerships, and accelerates delivery of world-class treatments to patients with unmet needs.
Gaithersburg, MD is one of AstraZeneca’s major R&D hubs, offering a collaborative and inclusive work culture where employees are encouraged to bring their best selves to work.
Role Overview
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership across the development, commercialization, and lifecycle management of assigned oncology products.
This position acts as:
Global Regulatory Lead (GRL) for early-stage programs or specific indications, and/or
Regional Regulatory Lead for designated markets.
The RAD shapes regulatory strategy, drives global submissions, and leads health authority interactions to secure rapid approvals and optimal labeling.
Key Responsibilities
1. Regulatory Strategy & Leadership
Lead cross-functional teams for major submissions (NDA, BLA, IND, CTA).
Develop and execute global/regional regulatory strategies to achieve rapid approvals with competitive labeling.
Prepare regulatory strategy documents and target product labeling.
2. Health Authority Engagement
Craft and lead the global health authority interaction strategy.
Drive creation of briefing documents with strong scientific and strategic content.
Lead rehearsals and moderate meetings with regulatory agencies.
Own negotiations with health authorities and lead preparation of key regulatory documents.
3. Team Leadership & Collaboration
Lead a Global Regulatory Strategy Team (GRST) comprising regional representatives, RA CMC, labeling, and execution teams.
Mentor GRST members and provide performance feedback.
Partner with global marketing companies and regional regulatory teams to influence evolving regulatory expectations.
4. Submission & Dossier Management
Plan and construct the global dossier and core prescribing information.
Oversee product maintenance, supply, and compliance-related regulatory activities.
5. Risk & Data Assessment
Deliver regulatory milestones including risk assessment, mitigation planning, and evaluation of emerging data.
Assess the probability of success and ensure alignment with clinical and business objectives.
Minimum Qualifications
Bachelor’s degree in a science-related field.
Minimum 3 years of regulatory strategy experience or equivalent knowledge.
Strong understanding of regulatory affairs in at least one therapeutic area, across early and late development.
Demonstrated experience in drug development and major health authority interactions.
Skills in strategic thinking, risk evaluation, innovation, leadership, and communication.
Preferred Qualifications
Advanced degree (MSc, PhD, PharmD, MD).
Experience in Hematology / Hemato-Oncology.
Prior involvement in Phase 3 study design and End-of-Phase 2 health authority engagements.
Contribution to at least one regulatory approval, including labeling negotiations.
Strong understanding of drug development principles: benefit–risk evaluation, dose selection, statistical design.
Broad experience across multiple areas of regulatory affairs.
Ability to lead within a high-profile, business-critical development program.
Strong grasp of current global regulatory science questions and related clinical/scientific aspects.
Compensation & Benefits
Annual Base Salary Range: $186,232 – $279,349
(Final offer depends on location, skills, and experience)
Short-term incentive bonus eligibility
Equity-based long-term incentive program (for salaried roles)
Retirement benefits (401k)
Paid vacation, holidays, and leaves
Health benefits including medical, dental, vision, and prescription coverage
Hybrid working model: 3 days per week in office
Employment is at-will, with potential salary adjustments based on performance and market factors.
Diversity & Inclusion
AstraZeneca is dedicated to building an inclusive and diverse workplace. All qualified applicants are encouraged to apply regardless of protected characteristics.
Candidates with disabilities or special accommodations may indicate this during the application process.
Next Steps
Apply today to join AstraZeneca in advancing breakthrough oncology treatments and shaping the future of global regulatory science.
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