Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Director, Regulatory Affairs will be responsible for regulatory evaluation of assets brought forward as potential acquisitions or partnering opportunities for Alexion. This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for strategic business development activities. The individual will also ensure effective communication and constructive working relationships with business partners within and outside of Alexion.
Participate on cross-functional asset review teams to provide strategic regulatory input.
Conduct due diligence on proposed assets, focusing primarily on regulatory aspects but also providing broader input based on development experience and expertise.
Review potential in-licencing assets to assess regulatory probability of success and to understand likely regulatory risk
Manage seamless transition to Alexion GRA Portfolio Product staff following completion of acquisition activities.
Provides advice on regulatory issues for potential assets; 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.).
Monitor the development of new regulatory requirements or guidance documents and advise asset 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 in strategic regulatory due diligence for products at all stages of development from early stages to approval.
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
10 years in pharmaceutical industry regulatory affairs
Employer will assist with relocation costs.
Internal Number: 15078
About Alexion Pharmaceuticals
Alexion (NASDAQ: ALXN) is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies.
Since its founding in 1992, Alexion has given hope to people who had none and shined a light on those who felt isolated and alone. But we know that fighting rare diseases takes so much more than hope. It requires persistence, dedication, and a relentless pursuit of the highest levels of medical innovation. At Alexion, our goal is to deliver medical breakthroughs where none currently exist. We are driven because we know people's lives are at stake.
Alexion has 2,500 passionate and dedicated employees serving patients in 50 countries around the world.