Manager, Global Regulatory Strategy

Location : Gaithersburg

Additional location : Boston Seaport

Hybrid: 3 days a week onsite

About Alexion 

For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and an unrelenting commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. 

Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered. You'll join a community that puts patients first, plays to win, and supports your development at every step. 

This is what you will do:

The  Manager – Global Regulatory Strategy Lead will be responsible for  developing and implementing US regulatory strategy leading to successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual will, with a high sense of urgency,  provide strategic regulatory input and execution support to assigned programs, ensuring effective regulatory planning, high-quality deliverables, and constructive collaboration with cross-functional business partners and representatives of regulatory authorities.

You will be responsible for:

• Serves as the US regulatory lead on assigned programs , developing and directing innovative and effective US regulatory strategies in support of the assigned Alexion portfolio, pipeline, and therapeutic areas.

• Represents Alexion as point of contact with regulatory authorities , including supporting and coordinating regulatory meetings and development of information packages.

• Provides regulatory advice on pipeline products and line extensions for marketed products , actively collaborating with regulatory management and cross-functional colleagues across Alexion.

• Prepares and executes aspects of global and regional regulatory affairs , ensuring integration of local objectives into global regulatory strategy.

• Coordinates submissions to regulatory authorities in support of proposed and ongoing development programs and acts as lead for local marketing authorization applications (e.g. NDA, BLA).

• Monitors the development of new regulatory requirements and guidance documents and advises product teams of the impact on the business or development programs.

• Contributes to effective ways of working and consistent regulatory practices , helping to support high-quality execution across programs and regulatory activities.

• Ensures  exemplary behavior, ethics and transparency within the company and with regulatory agencies.

You will need to have:

Qualifications

• 5+ years of experience in pharmaceutical industry regulatory affairs.

• Bachelor's Degree, preference to a scientific or a clinical degree.

• Strong knowledge of drug development and regulatory policy, with excellent scientific and business judgment.

• Experience providing  strategic regulatory advice for the global development of products through all stages of development, including pre-approval and marketed compounds.

• 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 , with solid understanding of where to seek and how to interpret regulatory information.

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Why Alexion?

At Alexion (AstraZeneca’s Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across disciplines to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and empathy for patients and communities we serve. 

If this opportunity to redefine what patient engagement can be resonates, apply now to start the conversation! 

The annual base pay for this position ranges from $109,244.80 - $163,867.20 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.