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.
- Bachelor's Degree in a related discipline
- 7 years in pharmaceutical industry regulatory affairs