COMPLETE Lead Counsel Regulatory, Safety & PhV - EMEA, CH, Kanton Bern, Bern, CSL Behring

Purpose:

Global lead counsel responsible for establishing and leading the Regulatory, Safety and Pharmacovigilance legal center of excellence (COE), including providing and coordinating specialist legal advice on regulatory, safety and pharmacovigilance matters in CSL’s key jurisdictions, on an enterprise wide basis.

Responsibilities:

• Provide Specialist Legal Advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety & Pharmacovigilance (GCSP) organizations on a broad range of legal and regulatory issues related to the Group s R&D pipeline, on-market products and lifecycle management initiatives, including product registration and regulatory strategy, labeling, data exclusivity, regulatory supply chain issues, reporting, import and export requirements, GxP matters, clinical safety, pharmacovigilance, product recalls, expanded access, orphan drug designation, fast track designation, breakthrough designation, early access or special access programs, accelerated approval and priority review. Advise on compliance with any regulatory post-market requirements.

• Serve as trusted legal partner on the Global Regulatory and Clinical Safety leadership teams, andto the EU QPPV.

• Represent Legal on the Global Benefit Risk Committee

• Provide legal support and strategic advice to CSL’s interactions with international regulatory agencies and health authorities, including the development of legal arguments for inclusion in regulatory submissions and assisting with preparations for formal meetings with agencies and advisory committee meetings.

• Support the regulatory and safety aspects of CSL’s licensing and M&A transactions, including by supporting regulatory and safety due diligence, negotiating key regulatory and safety terms andm supporting any post-transaction integration and other activities. Act as a key liaison between the deal team and CSL’s internal client group to ensure CSL’s functional and operational requirements with respect to safety and regulatory matters are accounted for in all transaction.

• Provide litigation support, in conjunction with General Counsel, Global R&D and Strategy and outside counsel, for regulatory and safety matters.

• Pro-actively develop and maintain a broad and deep knowledge of applicable laws and regulations, industry practices and standards, as well as key developments in the global regulatory environment relevant to CSL’s business

• Participate and represent CSL in external industry forums and networks as appropriate.

• Develop and deliver training to the business on regulatory, safety and pharmacovigilance legal matters as required or requested.

• Develop a suite of template clauses and agreements necessary to support key pharmacovigilance and safety matters.

Qualifications:

• Bachelor’s degree and J.D. or equivalent foreign degree 

• Bar admission in relevant region or permission to practice in-house

• Minimum of 12 years' experience providing legal advice on regulatory, safety and

  pharmacovigilance issues to pharmaceutical or biotechnology companies, either in-house

  or at a law firm with a reputable regulatory life sciences practice

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!