Manager, Global Regulatory Strategy

Alexion•Gaithersburg, MD

5d•Hybrid

About The Position

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.

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.

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.