Regulatory Exclusivity Expert with IP Litigation Experience
Vor 3 Tagen
We are seeking an experienced Regulatory Exclusivity Expert with IP Litigation Experience to join our team. The ideal candidate will have a strong background in IP litigation, particularly in the area of biologics, and excellent knowledge of regulatory exclusivity and related legislations. This is an excellent opportunity to work on challenging projects and contribute to the company's success.
About Us
CYLtur laboratories is a leading developer of high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in various therapeutic areas. We are committed to making a positive impact on patients' lives and strive to be at the forefront of innovation in the pharmaceutical industry.
Key Responsibilities
- Develop and implement life cycle management strategies for biologics, focusing on regulatory exclusivity and patent term extensions
- Provide expert advice on IP litigation, including patent litigations strategies with emphasis on regulatory exclusivity linkage
- Collaborate with cross-functional teams to secure and 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 such as risk management plans, side effects, and precautions
- Build and lead high-performing teams, developing, mentoring, and coaching team members to achieve optimal results in IP litigation cases
- Ensure consistent approaches towards life cycle management and loss of exclusivity strategies across the organization
Requirements
- At least 15+ years ex-US IP litigation experience with focus on biologics IP litigation (brand on brand or biosimilar)
- Excellent understanding of IP, Pharmaceutical Incentives, and associated regulatory legislations
- Strong experience in developing and implementing life cycle management and loss of exclusivity strategies
- Demonstrated ability to achieve optimal results in IP litigation cases; experience in Pharmaceutical Incentives / Regulatory exclusivity disputes advantageous
- Ability to solve complex and challenging problems
- Practical and creative mindset
- Demonstrated business acumen and ability to deliver useful advice
- Superior verbal and written communication skills and ability to communicate complex concepts to business partners in an understandable way
- Sound judgment
- Strong interpersonal and team player skills and the ability to effectively interact with people from diverse backgrounds
Benefits
CYLtur laboratories offers a comprehensive benefits package, including health care, financial protection, and other resources to support employees' wellbeing and career development.
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