Director, Regulatory Affairs – Regulatory Science and Execution
AstraZeneca
full-time
Posted on:
Location Type: Hybrid
Location: Maryland, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $173,601 - $260,401 per year
Job Level
Lead
About the role
- Own and drive regulatory strategy for late-stage or marketed products across US and other key global jurisdictions
- Design and implement submission strategies including INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans
- Serve as the Regulatory Lead and represent Alexion in interactions with Health Authorities (FDA, EMA, HC, MHRA)
- Lead execution of regulatory documentation, timelines, and team deliverables; collaborate with Regulatory Operations, Labeling, and CMC
- Stay current on regulatory trends, guidances, and policy shifts; support enterprise-level regulatory process development, audit readiness, and inspection response
- Provide mentorship and leadership to regulatory colleagues and cross-functional team members
Requirements
- 8+ years of experience in Regulatory Affairs within pharma or biotech, including US regulatory strategy and submissions
- Proven leadership in global regulatory strategy across the drug development lifecycle
- Deep understanding of the drug development process, global regulatory frameworks, and rare disease or specialty drug pathways
- Track record of leading meetings with Health Authorities and managing complex regulatory submissions
- Strong working knowledge of GxPs, emerging regulations, and regulatory intelligence tools
- Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments
- Exceptional collaboration and communication skills — able to influence at all levels, including senior leadership
Benefits
- short-term incentive bonus opportunity
- eligibility to participate in our equity-based long-term incentive program
- qualified retirement program [401(k) plan]
- paid vacation and holidays
- paid leaves
- health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategysubmission strategiesINDsCTAsBLAsNDAsOrphan Drug Designationpediatric plansregulatory documentationdrug development lifecycle
Soft skills
leadershipmentorshipcollaborationcommunicationstrategic thinkingrisk managementinfluence