Senior IP Litigator and Regulatory Exclusivity Expert

vor 1 Woche

Bern, Bern, Schweiz CSL Vollzeit
Job Title: Senior IP Litigator and Regulatory Exclusivity Expert

The position is for a senior lawyer to provide advice, assistance, and leadership on regulatory issues integral to the exclusivity position of a product, particularly regarding regulatory exclusivities. The role includes developing strategies to create synergies with IP exclusivities to optimize life cycle management (LCM), creating optimal exclusivities for development/pipeline products, and managing the loss of exclusivity (LoE) position of CSL's products.

Key Responsibilities:
  • Stay up-to-date with regulatory and pharmaceutical incentives legislations in the 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 the 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 members and business partners.
  • Design and support periodic exclusivity reviews to 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 (LCM) strategies and loss of exclusivity (LoE) strategies.
  • Design and coordinate the 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.
Requirements:
  • At least 15+ years ex-US IP litigation experience with a focus on biologics IP litigation (brand on brand or biosimilar).
  • At least 10+ years experience in life cycle management and loss of exclusivity strategizing.
  • At least 10+ years experience in handling complex IP incentives and regulatory strategies or disputes.
  • At least 10+ years experience litigating and resolving IP and regulatory exclusivity related contract disputes.
  • At least 10+ years experience monetizing IP assets.
  • Experience leading a team of in-house IP lawyers.
Competencies:
  • 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 of advantage.
  • Excellent negotiation skills.
  • 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.
  • Ability to prioritize and effectively handle multiple projects at the same time.
  • Comfortable working on teams and independently.
  • Agile learner capable of stepping quickly into new situations.
Leadership Competencies:
  • Strategic thinking.
  • Building and optimizing teams.
  • Developing, mentoring, and coaching team members.
About CSL Behring:

CSL Behring is a global leader in developing and delivering 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 the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

  • Senior IP Litigator and Regulatory Exclusivity Expert

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Title: Senior IP Litigator and Regulatory Exclusivity ExpertThe position is for a senior IP litigator and regulatory exclusivity expert to provide advice, assistance, and leadership on regulatory issues integral to the exclusivity position of a product, particularly regarding regulatory exclusivities, developing strategies that create synergies with IP...

  • Senior IP Litigator and Regulatory Exclusivity Strategist

    vor 1 Monat

    Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryCSL is seeking a highly experienced Senior IP Litigator and Regulatory Exclusivity Strategist to join our team. As a key member of our global IP leadership team, you will be responsible for providing strategic advice and guidance on regulatory exclusivity and IP litigation matters.Key ResponsibilitiesDevelop and implement life cycle management and...

  • Regulatory Strategy Manager

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking an experienced and skilled Regulatory Affairs professional to lead the development of regional strategies and contribute to global regulatory strategies for the Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of the Global Regulatory Affairs team, you will be responsible for submitting regulatory...

  • Regional Regulatory Affairs Specialist

    Vor 5 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking a highly experienced Regulatory Affairs Specialist to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Affairs team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change...

  • Regional Regulatory Affairs Specialist

    Vor 4 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking a highly experienced Regulatory Affairs Specialist to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Strategy Team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change...

  • Senior SAP PS-PPM Consultant

    Vor 4 Tagen

    Bern, Bern, Schweiz Dabster Vollzeit

    Job Title: Senior SAP PS-PPM ConsultantJob Type: Permanent (% Remote Possible)We are seeking a highly skilled Senior SAP PS-PPM Consultant to join our team at Dabster. As a key member of our organization, you will be responsible for providing expert-level support in portfolio and project management using SAP PS-PPM. Your primary focus will be on delivering...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bern, Bern, Schweiz bruederlinpartner Vollzeit

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at bruederlinpartner. As a Regulatory Affairs Manager, you will be responsible for developing and implementing regulatory strategies, ensuring compliance with national and international regulations, and coordinating with internal departments, external advisors, and...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will be responsible for ensuring the development and upkeep of regulatory documentation to guarantee compliance with global standards.Develop and execute regulatory strategies aligned with...

  • Senior Scientific Expert Quality Control Specialist

    vor 2 Monaten

    Bern, Bern, Schweiz CSL Behring Vollzeit

    About the RoleWe are seeking a highly skilled Senior Scientific Expert Quality Control Specialist to join our team at CSL Behring. In this position, you will play a critical role in supporting the Quality Control activities and projects within our organization.Key ResponsibilitiesProduct Specifications: Develop and maintain product specifications, ensuring...

  • CMC Quality By Design Expert

    Vor 6 Tagen

    Bern, Bern, Schweiz Consultys Vollzeit

    Job SummaryAs a CMC Quality By Design Consultant at Consultys, you will be responsible for leading small expert teams to compile quality by design and regulatory dossier information. Your expertise in QbD process development, scale-up, technology transfer, process validation, and CMC regulatory affairs will be essential in driving quality results in a...

  • Senior Payroll Specialist Switzerland

    Vor 7 Tagen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryThe Senior Payroll Specialist position at CSL Behring is responsible for the accurate and timely processing of Swiss payrolls. Reporting to the Senior Payroll Manager Switzerland, the specialist serves as the key point of contact and subject matter expert for the payrolls they support.Key ResponsibilitiesEnsure payrolls are processed in accordance...

  • Senior Payroll Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Senior Payroll Specialist Job DescriptionThe Senior Payroll Specialist position at CSL Behring is a critical role that requires expertise in payroll processing for Swiss payrolls. As the key point of contact and subject matter expert, the specialist will work closely with the Payroll Vendors to ensure accurate and timely payroll processing, while also...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will be responsible for ensuring the development and upkeep of regulatory documentation to guarantee compliance with global standards.Key responsibilities include:Developing and executing...

  • CMC Quality By Design Expert

    Vor 4 Tagen

    Bern, Bern, Schweiz Consultys Vollzeit

    Job Title: CMC Quality By Design ExpertAbout the Role:We are seeking a highly skilled CMC Quality By Design Expert to join our team at Consultys. As a key member of our team, you will be responsible for leading small expert teams to compile Quality by Design and regulatory dossier information. Your expertise in QbD process development, scale-up, technology...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will play a critical role in ensuring the development and upkeep of regulatory documentation to ensure compliance with global standards.Develop and execute regulatory strategies aligned with...

  • Regional Regulatory Lead Immunology

    vor 2 Wochen

    Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    {"title": "Regulatory Affairs Specialist Immunology", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Immunology team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local and regional regulations, communicating effectively with regulatory agencies, and...

  • Senior Payroll Specialist

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Senior Payroll Specialist Job DescriptionThe Senior Payroll Specialist position at CSL Behring is a critical role that requires expertise in payroll processing for Swiss payrolls. As the key point of contact and subject matter expert, the specialist will work closely with the Payroll Vendors to ensure accurate and timely payroll processing, while also...

  • Senior Software Engineer

    vor 4 Wochen

    Bern, Bern, Schweiz ONE Agency | IT Recruitment Experts Vollzeit

    Job DescriptionONE Agency | IT Recruitment Experts is seeking a highly skilled Senior Software Engineer to join our team. As a Senior Software Engineer, you will be responsible for developing and implementing modern applications, analyzing customer requirements, and creating specifications.Key Responsibilities:Develop and implement modern applicationsAnalyze...

  • Senior Scientific Expert Quality Control Specialist

    vor 1 Monat

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Scientific Expert Quality Control Specialist to join our team at CSL Behring. In this role, you will be responsible for supporting the Quality Control activities and projects within our Quality Control department.Key ResponsibilitiesProduct SpecificationsEstablish and amend product specifications in a timely...

  • Regional Regulatory Lead Immunology

    vor 3 Wochen

    Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    Job SummaryWe are seeking a highly skilled Regional Regulatory Lead Immunology to join our team at Gi Life Sciences Basel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and aligning regulatory activities with regional and global strategies.Key ResponsibilitiesLead regional regulatory...