Senior IP and Regulatory Exclusivity Lawyer
2 months ago
CSL Company is seeking a highly skilled Senior IP and Regulatory Exclusivity Lawyer to join our team. As a key member of our global IP leadership team, you will play a critical role in providing strategic advice and leadership on regulatory issues related to exclusivity positions of our products.
Key Responsibilities:- Provide expert advice on regulatory exclusivity and IP strategies to optimize life cycle management (LCM) and loss of exclusivity (LoE) positions.
- Develop and implement strategies to create synergies between regulatory and IP exclusivities.
- Coordinate complex regulatory exclusivity and related activities, including LoE strategies, taking into account the IP landscape and broader political and commercial environment.
- Support the global IP organization in implementing 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 regulatory exclusivity aspects.
- Advise on patent litigations strategies with an emphasis on regulatory exclusivity linkage.
- Ensure consistent approaches towards life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies across the global IP organization.
- Collaborate with Global Regulatory and R&D to secure/maximize value creation through Patent Term Extensions, Patent Linkage, Paediatric Extension, and review of critical registration dossier sections.
- Guide patent drafting and prosecution on the basis of regulatory and pharmacovigilance innovation.
- Build and lead a 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.
- Negotiate settlements and license agreements.
- Advise RoW business partners regarding IP strategy and litigation risk.
- Support professional development of functional RoW IP litigation team members.
Requirements:
- Strong expertise in regulatory exclusivity and IP law.
- Excellent strategic thinking and problem-solving skills.
- Ability to collaborate effectively across functions with multiple stakeholders.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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