Alexion Pharmaceuticals, Inc. · 3 days ago
Associate Director, Global Labelling Strategy
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Lead/Staff, Director/Executive
$135K/yr - $203K/yr
2+ years expAlexion Pharmaceuticals, Inc. is seeking an Associate Director for their Global Labelling Strategy team within the Respiratory and Immunology (R&I) department. This role involves providing regulatory strategic labelling expertise, developing and implementing labelling strategies, and ensuring compliance with regulatory requirements for marketed or pipeline products.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio
Lead the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents (QRD), US Prescribing Information (PI), and Instructions for Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling
Lead the development of labelling negotiation strategies, anticipating health authority perspectives
Provide labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance
Provide clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations
Evaluate, interpret and communicate global regulations and trends on labelling and any business impact these might have on product labelling
Lead the development of Target Product Labelling (TPL) documents
Assist in the development of labelling documents, policies, procedures and SOPs
Ensure that the labelling process is followed through the lifecycle of the product
Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs
Qualification
Required
Bachelor's degree in Science or related discipline
2 - 4 years of pharmaceutical experience, including regulatory and labelling experience
Ability to assimilate clinical and scientific information and present it in a concise manner
Knowledge of labelling regulations and guidance
Excellent verbal and written communication skills
Keen attention to detail and accuracy
Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Must demonstrate competencies in building relationships, negotiation skills, critical information seeking, rational persuasion, interpersonal awareness
Preferred
Advanced academic training is highly desirable (PharmD, PhD)
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.
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
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2025-12-20
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