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ROW IP Litigator and Regulatory Exclusivity Expert, Bern
Client: CSL
Location:
Job Category: Other
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Job Reference: 2a01f526aab1
Job Views: 3
Posted: 03.06.2025
Expiry Date: 18.07.2025
Job Description:
The position is for an IP and Regulatory exclusivity (Pharmaceutical Incentives) senior lawyer. The role involves providing advice, assistance, and leadership on regulatory issues related to product exclusivity, developing strategies to optimize lifecycle management (LCM), and managing loss of exclusivity (LoE) positions for CSL’s products.
This IP lawyer will coordinate complex regulatory exclusivity activities, considering the IP landscape and broader political and commercial environments. The position reports to the head of IP and is part of the global IP leadership team.
The Role
* Stay updated on EU and global pharmaceutical legislation and regulatory developments.
* Support implementation of EU Pharma legislation and transparency rules.
* Design and support LCM and LoE strategies focusing on regulatory exclusivity.
* Conduct periodic reviews of pipeline products to maximize exclusivity.
* Advise on patent litigation strategies linked to regulatory exclusivity.
* Ensure consistent approaches to LCM and LoE strategies across the organization.
* Coordinate collaboration with Regulatory and R&D teams to maximize value (e.g., Patent Term Extensions, Patent Linkage).
* Guide patent drafting and prosecution considering regulatory and pharmacovigilance aspects.
* Build and lead teams for LCM/LoE and IP litigation, including managing disputes, negotiations, and licensing.
* Advise business partners on IP strategies and litigation risks.
* Manage governance, reporting, and budgets for IP litigation.
* Monetize IP assets through licensing and enforcement.
* Collaborate across functions with multiple stakeholders.
Skills and Experience
* 15+ years of ex-US IP litigation experience, particularly in biologics IP litigation.
* 10+ years in lifecycle management and LoE strategies.
* 10+ years handling complex IP incentives and regulatory disputes.
* Experience in monetizing IP assets and leading IP teams.
* Strong understanding of IP, pharmaceutical incentives, and regulatory laws.
* Proven ability to achieve results in IP litigation and regulatory disputes.
* Excellent communication, judgment, and interpersonal skills.
* Ability to prioritize and manage multiple projects effectively.
* Leadership skills including strategic thinking, team building, mentoring, and coaching.
CSL offers benefits from day one for employees working at least 30 hours per week, supporting health, financial security, and personal development. We are committed to employee wellbeing and offer resources for various life stages and needs.
CSL Behring is a global leader in medicines for rare and serious diseases, serving over 100 countries in areas such as immunology, hematology, cardiovascular, respiratory, and transplant.
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