Alexion Pharmaceuticals Associate Director, Global Regulatory Affairs Development Strategy in Boston, Massachusetts
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 management to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.
Serves 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, coordinating, and leading regulatory meetings and information package development.
Leads submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new marketing authorization applications, pediatric strategy, orphan drug designation applications, clinical trial application submissions, amendments, etc.
Monitors the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
May manage a team staff of junior level Specialists.
May provide 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.
This position can be based in Blue Bell, PA, San Francisco, CA, Boston, MA, or remote/virtual.
Bachelor’s Degree in a related discipline
7 years in pharmaceutical industry regulatory affairs