The Head of Regulatory Affairs Strategy, Innovative Portfolio will have direct oversight to lead the global, US, and EU regulatory strategy and delivery associated with the innovative portfolio working in partnership with the Global Program Teams, other functions in R&D, commercial, and GPS. Key focus is on new MOAs, drug delivery systems, drug-device combinations, biologics and in the rare disease space.

Responsibilities

• Provide leadership of global, US, and EU regulatory leads to create and drive the regulatory strategy for the innovative portfolio and ensure that there is a sound regulatory foundation to help drive the clinical development and LCM opportunities of the portfolio.
• The leader and their team have primary responsibility for the global regulatory strategy, regulatory interactions, and submissions, with direct accountability for US and EU centralized procedure and input with EU affiliates for national procedures (where applicable).
• Plays a leadership role providing management and guidance across the strategy function.

Educational

• Master's or bachelor's degree within science e.g. pharmaceutics, biomedicine, chemistry or a related field. Advanced degree preferred.

Professional

• Master's or bachelor's degree within science e.g. pharmaceutics, biomedicine, chemistry or a related field. Advanced degree preferred.

• 2+ years pharmaceutical industry and 10+ relevant global strategic regulatory experience and 7+ years managerial experience (resource, capacity, performance and change management)

• In-depth therapeutic strategy RA experience on a global level for both development and maintenance phases for pharmaceuticals.

• Solid knowledge of the regulatory framework.

• Excellent strategic thinking.

• Solid stakeholder management skills.

• Commercial understanding.

• Sound understanding of the drug development process with specific focus on drug development from early research through life cycle management considerations.

• Excellent ability to identify multiple regulatory opportunities, whilst being able to clearly communicate regulatory constraints, risks, and identify various risk mitigation strategies to support business objectives.

• Must be able to perform all essential functions of the position, with or without reasonable accommodation