Lead Counsel Regulatory, Safety
Vor 5 Tagen
**Purpose**:
Lead counsel responsible for providing and coordinating specialist legal advice on safety and pharmacovigilance matters in CSL’s key jurisdictions, and strategic and specialist legal advice on regulatory matters.
**Responsibilities**:
- Provide specialist legal advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety & Pharmacovigilance (GCSP) organizations on a broad range of 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
- Provide legal support for 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 aspects of CSL’s licensing and M&A transactions, including by supporting regulatory due diligence, negotiating key regulatory terms and supporting any post-transaction integration and other activities.
- Provide litigation support, in conjunction with Associate General Counsel, R&D and Strategy and outside counsel, for regulatory and safety matters.
- 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.
- Advise management at a strategic level and on major tactical initiatives and participate actively as a member of the Senior Leadership Team.
- Develop and deliver training to the business on regulatory, safety and pharmacovigilance legal matters as required or requested.
**Qualifications**:
- Bachelor’s degree and J.D. or equivalent foreign degree
- Bar admission in relevant region or permission to practice in-house
- Minimum of 7 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**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**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 organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
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