Senior IP Lawyer and Regulatory Strategist

Vor 4 Tagen

Bern, Bern, Schweiz CSL Vollzeit

Job Summary


Career opportunities for Senior IP Lawyer and Regulatory Strategist at CSL Behring, a global leader in developing and delivering high-quality medicines for rare and serious diseases.


About the Role


This Senior IP Lawyer and Regulatory Strategist position is responsible for providing advice, assistance, and leadership on regulatory issues that are integral to the exclusivity position of our products, particularly regarding regulatory exclusivities, developing strategies to optimize life cycle management, and creating synergies with IP exclusivities.


Key Responsibilities


• Provide expert advice on regulatory and pharmaceutical incentives legislations in the EU and 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 and loss of exclusivity strategies with a focus on regulatory exclusivity aspects in collaboration with IP team members 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 litigation strategies with an emphasis on regulatory exclusivity linkage
• Ensure the global IP organization takes consistent approaches towards life cycle management and loss of exclusivity strategies
• Design and coordinate implementation of collaboration streams with Global Regulatory and R&D to secure/maximize value creation
• Guide patent drafting and prosecution on the basis of regulatory and pharmacovigilance innovation such as risk management plans, side effects, and percations
• Build a life cycle management/loss of exclusivity 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

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