Shire Jobs

Provide strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for assigned projects. Lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategy. As the primary regulatory interface within CSL Behring for Global Regulatory Affairs (GRA) on specific development projects, ensure collaboration with key internal stakeholders of the Project Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development Team to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables. Accountable for the delivery of successful regulatory license applications globally, including new product development and product life cycle management related to new indications. Provide clinical related input for late life cycle products independent of development phase. In partnership with Regional Leads, accountable to pro-actively support the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned therapeutic areas and products. Responsible for regulatory strategic input and decisions necessary to ensure development and execution of successful global regulatory strategies, submissions and approvals for assigned project(s) at all stages. May work from home.

SPECIAL REQUIREMENTS:     

• 8 years of Regulatory experience with 5 years of that time in a developmental stage organization.
• 3 years of experience in leading and managing matrix teams.

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time". Required expertise/knowledge includes:

• Experience in the development of drug/device combination products or drug delivery systems.
• Medical device design control experience.
• Experience in setting clear direction, holding people accountable and fostering a collaborative team environment.
• Understanding of pharmaceutical/biological/medical device product development and regulatory requirements for product development and approval in Europe, United States and Japan.
• Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (United States and Europe).
• Experience interfacing with regulatory agencies and developing and implementing successful global regulatory strategies.
• Experience in working with multiple stakeholders.
• Clinical regulatory foundation and/or management experience.