Senior Director Specialty Therapeutic Group, Global Regulatory Affairs

In this role one will ensure the development of appropriate regulatory strategy(ies) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Evidence Plan (IEP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile.

Key Responsibilities

• To proactively develop a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Ensure implementation of the regulatory strategy(ies) in support of the project priorities.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
• Lead regulatory interactions and Health Authority submission/review processes.
• Ensure effective interaction with local regulatory counterparts in prior...