Alexion Pharmaceuticals Associate Director, Regulatory Affairs Development Strategy in France
The Associate Director, Global Regulatory Affairs Development Strategy (GRA-DS) will be responsible for 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. This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Works with manager to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.
May serve as global regulatory team leader on assigned programs.
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.).
Prepares and executes region-specific aspects of regulatory affairs, and ensures integration into global regulatory strategy.
Represents Alexion as point contact with regulatory authorities, including providing 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 application submissions, amendments, etc.
Monitor the development of new regulatory requirements or guidance documents and advise 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
7 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.