Senior Regulatory Affairs Director (Rare Diseases)
Location: Boston, Massachusetts, United States
Job ID: R-239280
Date Posted: 11/11/2025
Closing Date: 18/11/2025
Role Overview
The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will oversee the development of global regulatory strategies for products targeting rare diseases and unmet medical needs. The position emphasizes leading cross-regulatory teams, managing complex product lifecycles, and ensuring strong collaboration with internal and external stakeholders, including regulatory authorities.
Key Responsibilities
1. Regulatory Strategy & Leadership
Develop and oversee global regulatory strategies for assigned therapeutic areas/products.
Provide regulatory strategic oversight from initial development through lifecycle management.
Ensure strategies align with Enterprise objectives.
2. Cross-Functional Collaboration
Lead and support teams during regulatory authority meetings.
Provide input to submission strategies and critical regulatory documents.
Represent Alexion in interactions with Health Authorities as needed.
Collaborate with senior management and enterprise functions (Clinical, Medical Affairs, Commercial).
3. Governance & Advisory Support
Provide input to internal governance bodies for strategic and operational regulatory issues.
Stay updated on regulatory trends and help shape the regulatory science environment.
Support regulatory intelligence, policy priorities, and business development activities (e.g., due diligence, resource planning).
4. Compliance & Ethics
Ensure high ethical standards, transparency, and compliance in interactions with Health Authorities and partners.
Qualifications
Essential Requirements
10+ years of regulatory experience in the pharmaceutical industry.
Proven experience in global regulatory strategies.
Strong understanding of drug development, regulatory policy, and scientific judgment.
Experience in global markets: US, EU, China, Japan.
Successful track record in product registration and lifecycle management.
Ability to handle complex issues and manage multiple projects.
Strong interpersonal, leadership, and communication skills.
Deep understanding of new/emerging regulations, guidances, and GxPs.
Proficiency in identifying and interpreting regulatory information.
Education
Bachelor’s degree in life sciences preferred.
MSc/PhD is an added advantage.
Relevant certifications or training preferred.
Competencies
Strong skills in Microsoft 365, especially PowerPoint.
Proficiency in English (corporate level).
Additional languages are a plus.
Compensation & Benefits
Annual base salary: $211,581.60 – $317,372.40
(Varies based on location, experience, skills, and performance.)
Short-term incentive bonus eligibility.
Long-term equity incentive program (for salaried roles).
401(k) retirement program.
Paid vacation, holidays, leaves.
Comprehensive medical, dental, vision benefits.
Work Mode:
Hybrid — expected to work in-office 3 days a week.
Employment Type:
“At-will” position — compensation may be modified based on performance, team output, or market factors.
Equal Opportunity
Alexion is committed to an inclusive environment with equal opportunities for all applicants. Candidates with disabilities or special needs can request reasonable accommodations during the application process.
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