ROW IP Litigator and Regulatory Exclusivity Expert

This a Full Remote job, the offer is available from: EMEA The position is for an IP and Regulatory exclusivity (Pharmaceutical Incentives) senior lawyer. The position includes providing advice, assistance and leadership on regulatory issues which are integral part of the exclusivity position of a product, in particular regarding regulatory exclusivities, developing strategies that will create synergies with IP exclusivities to optimize life cycle management (LCM), the optimal creation of exclusivities for development/pipeline products and the loss of exclusivity (LoE) position of CSL’s products. This IP lawyer will coordinate complex regulatory exclusivity and other related activities , e.g. LoE strategies, taking into account the IP landscape and broader political and commercial environment. This position reports to the head of IP and is a member of the enterprise global IP leadership team. The Role • Be up-to-date with Regulatory and Pharmaceutical Incentives legislations in EU and new regulatory developments globally to ensure proper implementation across the global IP organization • Support the global IP organization with respect to the implementation of the new EU Pharma legislation package and EU transparency rules • Design and support implementation of life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies with a focus on the regulatory exclusivity aspects in collaboration with IP team member(s) and business partners • Design and support periodic exclusivity reviews to our pipeline/development products to maximize the length and strength of regulatory and IP exclusivities • Advise on patent litigations strategies with an emphasize of regulatory exclusivity linkage • Ensure the global IP organization takes consistent approaches towards life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies. • Design and coordinate implementation of collaboration streams with Global Regulatory and R&D to secure/maximize value creation (Patent Term Extensions, Patent Linkage, Paediatric Extension, review of critical registration dossier sections) • Guide patent drafting and prosecution on the basis of regulatory and pharmacovigilance innovation such as risk management plans, side effects and percations; • Build a LCM/LoE functional team that works together on challenging problems and provides mutual support. • Conceive and execute RoW IP litigation strategies in collaboration with other team members • Directly manage certain RoW IP disputes or Pharmaceutical Incentives disputes • Negotiate settlements and license agreements • Advise RoW business partners regarding IP strategy and litigation risk • Build RoW IP litigation functional team that works together on challenging problems and provides mutual support • Support professional development of functional RoW IP litigation team members, including through mentoring, coaching, continuing legal education, and sharing of best practices • Ensure RoW IP litigation team takes consistent approaches towards handling cases • Manage governance and reporting of RoW IP litigation • Manage RoW IP litigation budget • Monetize IP assets via licensing and, if necessary, patent enforcement • Collaborate effectively across functions with multiple stakeholders