Manager, Global Regulatory Strategy

AstraZeneca•Boston, MA

6d•$109,245 - $163,867•Hybrid

About The Position

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.

Requirements

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.
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.

Responsibilities

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.