Alexion Pharmaceuticals, Inc. · 1 day ago
Regulatory Affairs Director, Global Regulatory Strategy
Gaithersburg, MD
Full-time
Onsite
Director/Executive
$186K/yr - $279K/yrAlexion Pharmaceuticals, Inc. is seeking a Regulatory Affairs Director for Global Regulatory Strategy. This role involves providing strategic regulatory advice, influencing regulatory agencies, and ensuring compliance across multiple markets while managing a small team.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions
Provides strategic regulatory advice support for product developments regional therapy area
Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Typical People Management Responsibility (direct / indirect reports):
Approximate number of people managed in total (all levels) - 0-5
Matrix Manager – (projects/dotted line) What is the global remit? (how many countries will the role operate in?): 4 or more countries at a minimum of 40% of time
Qualification
Required
Bachelor's Degree in Life Science or related discipline, advanced degree a plus
Significant experience of regulatory drug development, manufacture, commercialisation or equivalent
Proven successful leadership and project management experience
Broad background of experience of working in several groups in regulatory affairs or experience at a health authority
Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance
Preferred
Significant Regulatory Experience across global projects and regions
Strong commercial awareness
Problem solving skills
Focus on delivery and results
Excellent strategic influencing and negotiation
Develops collaborative working relationships
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
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.
Founded in 1992
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
bloomberglaw.com
2025-12-20
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