Vice President, Global Regulatory AffairsSome opportunities happen only once in a lifetime like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Location: Barcelona
Reports To: Senior Vice President, Head, Global Regulatory Affairs
This is what you will do: Lead the team of regulatory strategy professionals who develop and implement regulatory strategy leading to successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.Contribute to RQA objective definition, general management, and setting the appropriate cultural tone across the department.Develop Alexion's overall regulatory strategic capability through effective leadership of the Development Strategy team.Foster an inclusive environment of continuous improvement, open and effective communication, and personal development across GRADS.Provide strategic guidance to regulatory professionals across GRADS, through regular reviews of key development issues and ad hoc input on specific strategic topics.Ensure appropriate resourcing for GRADS Therapeutic teams and monitor workload across programs in collaboration with GRADS TA Leads.Monitor the development of new regulatory requirements or guidance documents and advise product team representatives of the impact on the business or development programs.Provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.Actively participate as a member of the RQA Leadership Team and may represent RQA on assigned Alexion governance and leadership teams.May represent Alexion on external policy committees (e.g., PhRMA, BIO, etc.).You will need to have: Bachelor's Degree in a related discipline.15 years in pharmaceutical industry regulatory affairs.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.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging.
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