Alexion Pharmaceuticals Director, Global Regulatory Affairs - Development Strategy in Boston, Massachusetts
This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA or be remote/virtual, based anywhere in the United states and may require up to 20% travel.
Developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Develops and directs innovative and effective regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.
Global regulatory lead (GRL) on assigned programs. As GRL, acts as primary regulatory contact for associated Global Development Team and leads Regulatory Subteam (RST) for the program in line with expectations outlined in the GRA RST Playbook.
Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
May prepare and execute local aspects of regional regulatory affairs, and ensures integration into global regulatory strategy. Alternatively, directs local staff to execute regional regulatory strategy.
Represents Alexion as point contact with regional health authority and leads Alexion delegation to regulatory meetings. Supervises junior regulatory staff to provide support for and coordination of regulatory meetings and information package development.
Coordinates submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial submissions, new marketing authorization applications, etc.
Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies.
Strong knowledge of drug development and regulatory policy; 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; solid understanding of where to seek and how to interpret regulatory information
Bachelor’s Degree in a related discipline
12 years in pharmaceutical industry regulatory affairs
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.