Alexion Pharmaceuticals, Inc. · 1 week ago
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
Gaithersburg, MD
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$134K/yr - $201K/yr
7+ years expAlexion Pharmaceuticals, Inc. is a biopharma company focused on rare diseases, and they are seeking an Associate Director of Regulatory Affairs to lead regulatory strategies for complex products. This role involves providing strategic input, managing submissions to regulatory authorities, and ensuring compliance with regulatory requirements to support the development of innovative therapies.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Working with manager to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas
Serving as US Strategy Lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Global Regulatory Team (GRT) for assigned programs
Providing advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.)
Preparing and executing US-specific aspects of regulatory affairs and ensures integration into global regulatory strategy
Representing Alexion as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development
Coordinating submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc
Monitoring the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment
Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies
Qualification
Required
Bachelor's Degree in life science
7 years in pharmaceutical industry regulatory affairs
Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment
Extensive experience providing US strategic regulatory advice for the global development of products through some stages of development
Experience leading submissions and FDA meeting
Ability to manage complex issues and coordinate multiple projects simultaneously
Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization
Strong interpersonal and written/verbal communication skills
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidances
Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information
Preferred
Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus
Additional certification and/or training relevant to the role over the past
Benefits
Short-term incentive bonus opportunity
Eligibility to participate in our equity-based long-term incentive program (salaried roles)
Receive a retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
Company data provided by crunchbase