Director, Sr. Global Regulatory Lead - Cardiorenal page is loaded## Director, Sr. Global Regulatory Lead - Cardiorenallocations: EMEA, CH, Glattbrugg, CSL Behringtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R-274381Position Purpose:The Director, Senior Global Regulatory Lead (Sr. GRL) in Global Regulatory Strategy (GRS) is a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as follows:* Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities.* Acts as a key member and single GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice.* Leads health authority interactions (FDA, EMA) and builds productive relationships to drive positive regulatory outcomes globally.* Engages GRAST members to deliver regulatory outputs, fosters accountability and collaboration, and serves as decision-maker/approver for regulatory deliverables. Ensures strong communication between regulatory and R&D teams.* For selected roles, manages Regional Regulatory Leads and supports their development and career growth.**Main Responsibilities and Accountabilities:*** Builds strong relationships with Product Strategy Teams, Clinical Development Teams, Safety Management Teams, and other stakeholders to ensure effective collaboration and communication.* Manages strategic relationships with key health authorities (FDA, EMA) and coordinates with regional leads for non-home country interactions.* Acts as the single GRA reviewer/approver for key deliverables and participates in regulatory due diligence and senior-level discussions.* Leads preparation of key regulatory documents and mentors GRAST members.* Utilizes regulatory intelligence, analytics, and cross-functional expertise to develop global regulatory strategies.* Promotes consistency, collaboration, and knowledge sharing across Global Regulatory Strategy teams.* Coaches team members (where applicable) to develop innovative solutions and ensure timely execution of regulatory strategies.* Applies CSL leadership capabilities and supports talent development, succession planning, and team empowerment.**Position Qualifications and Experience Requirements:*** Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science required. Advanced degree (MS, PhD, MD, DVM) or MBA preferred.* Minimum 10 years in biotech or pharmaceutical industry, including at least 8 years in regulatory affairs and 5 years with developmental products.* Experience leading teams (preferably 5 years), including decision-making and fostering collaboration.* Knowledge of product development and regulatory requirements across major regions (EU, US, Japan).* Experience interacting directly with at least one health authority.* Experience working in a complex, matrix environment preferred.## **Was wir bieten**Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **Über CSL Behring**CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über .## **CSL soll so vielfältig sein wie die Welt, in der wir leben**Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über bei CSL.## **Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!**
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