Regulatory Affairs Director, Global Regulatory Strategy
Location: Gaithersburg, Maryland, United States
Job ID: R-219208
Date Posted: 01/10/2025
Closing Date: 29/11/2025
Position Summary
The Regulatory Affairs Director (RAD), Global Regulatory Strategy is responsible for designing and executing global regulatory strategies for assigned products and therapeutic areas. The role focuses on achieving successful registration and lifecycle management of innovative and complex products serving patients with rare diseases and unmet medical needs.
The position involves leading cross-regulatory teams, providing regulatory insights to Global Program/Medicine Teams, and maintaining effective communication with internal partners and external regulatory authorities.
Key Responsibilities
1. Regulatory Strategy Leadership
Develop and oversee global regulatory strategies for assigned therapeutic areas or portfolios.
Ensure regulatory plans support initial product registration and lifecycle management.
Provide strategic input to submission strategies and regulatory documents.
Represent Alexion in interactions with Health Authorities when needed.
2. Cross-Functional Collaboration
Lead and support teams preparing for regulatory authority meetings.
Provide input to internal governance bodies on strategic or operational regulatory matters.
Collaborate with Clinical, Medical Affairs, Commercial, and other enterprise functions to integrate regulatory perspectives into drug development.
3. Regulatory Intelligence & Policy
Stay updated on latest regulatory requirements and industry trends.
Contribute to advancing the regulatory science environment.
Support regulatory intelligence activities and policy initiatives.
4. Ethics & Compliance
Demonstrate exemplary behavior, integrity, and transparency.
Maintain strong relationships with Health Authorities and external stakeholders.
Required Qualifications (Essential)
Experience
8+ years of regulatory experience in the pharmaceutical industry.
Strong track record in global regulatory strategy.
Experience supporting product development across all stages (pre-approval to marketed).
Proven success in product registration and lifecycle regulatory management.
Ability to manage complex issues and coordinate multiple projects.
Skills
Strong knowledge of drug development, regulatory policy, and GxPs.
Ability to interpret and apply regulatory guidelines.
Excellent interpersonal, written, and verbal communication skills.
Strong risk-assessment judgment.
Ability to collaborate across global teams and senior leadership.
Education
Bachelor’s degree (Life Sciences preferred).
Postgraduate degrees (MSc, PhD) are a plus.
Additional regulatory certifications or training preferred.
Competencies
Excellent command of Microsoft 365, especially PowerPoint.
Proficient corporate-level English; additional languages are a plus.
Why AstraZeneca?
AstraZeneca provides a collaborative, inclusive, and innovation-driven environment. Employees are empowered to push scientific boundaries and contribute to advancements that impact patients and society. The company fosters learning, growth, and teamwork.
Work Model
Hybrid — employees are expected to work 3 days per week onsite.
Flexibility to balance personal and professional commitments.
Compensation & Benefits
Annual Base Salary: $186,232.80 – $279,349.20
(Final offer depends on location, skills, experience, and performance.)
Short-term incentive bonus eligibility.
Long-term equity incentive program (for salaried roles).
401(k) retirement plan.
Paid vacation, holidays, and leaves.
Medical, dental, vision, and prescription drug coverage.
Employment Type: At-will — salary and compensation may be adjusted based on performance and other factors.
Equal Opportunity
AstraZeneca promotes an inclusive environment, welcoming applicants from all backgrounds. Applicants with disabilities can request reasonable accommodations through the application form.
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