The Senior Manager, Global Labeling and US Life Cycle Management (LCM), Global Regulatory Affairs, will be responsible for implementing regulatory strategy after successful FDA 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 and global regulatory leads to execute innovative and effective regulatory strategies in support of assigned Alexion product(s) in the US.
- Provides advice on regulatory issues for marketed products; attends regulatory sub team meetings for assigned products; actively collaborates with management and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, global drug safety, medical affairs, legal, manufacturing, quality, etc.).
- Works with Global Labeling team and Global Regulatory Leads on assigned US label updates
- Prepares and/or executes post marketing activities for US: annual reports, and supplements.
- Serves as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
- May support proposed and ongoing development programs, e.g., new IND submissions, IND amendments, etc. as needed.
- 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.
- Strong knowledge of labeling process and requirements in the US; ex-US experience a plus.
- 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
- 5 years in pharmaceutical industry regulatory affairs