Director, Regulatory Affairs US Lead
About The Position
The Director, Regulatory Affairs US lead will be accountable for the development, implementation, and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Requirements
- 8+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies.
- Bachelor's degree in life science required.
- Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment.
- Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s) (e.g., US, EU, Canada) for the global development of products through all stages of development including pre-approval and marketed assets.
- Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion.
- Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, including Senior Management.
- Strong interpersonal, written/verbal communication and presentation skills.
- Proven track record practicing sound judgment as it relates to risk assessment.
- Highly familiar and knowledgeable of new and emerging regulations and guidances.
- Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
- Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
- Experience working in a regulatory documentation system (like Veeva).
- Proficient in English in the Corporate setting.
Nice To Haves
- relevant postgraduate degree (e.g., MSc, PharmD, or PhD) is preferred.
- Additional languages desirable.
Responsibilities
- Serving as US Strategy Lead on assigned programs.
- Acting as submission sub-team lead for US submissions and core member of the Global Regulatory Team (GRT) for assigned programs.
- Representing Alexion as point contact with FDA, including leading and managing Agency meetings and providing support and coordination of briefing package development.
- Develops and directs innovative and effective regulatory strategies in support of assigned project(s)/product(s); actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, etc.).
- Monitors the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
- Ensures exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
