CSL
Senior Manager, Regional Regulatory Lead - US (Vaccines)
CSL, King Of Prussia, Pennsylvania, United States, 19406
Senior Manager, Regional Regulatory Lead - US (Vaccines)
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? This is a hybrid position and is onsite three days a week. You will report to the Executive Director Head Regulatory. Position Description Summary Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric-focus. Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners. Supporting, potentially leading, health authority interactions in stationed country (FDA or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities. Engaging GRAST members to achieve regulatory deliverables while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed. Main Responsibilities & Accountabilities As GRA representative, proactively contributes and builds effective relationships with respective members of Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and/or Device/EHT related development teams. Supports assigned product relationship with key health authorities (FDA & EMA), including CSL contact for home country and for content, plus approach, in all global health authorities. Single GRA reviewer, and as necessary approver, of deliverables generated from PST, CDT, SMT and related delivery teams. Lead GRA project deliverables and mentor GRAST members, as appropriate. Leverage GRAST, competitive regulatory intelligence/AI, business insights / analytics and other specialized regulatory functions to deliver Global Regulatory Strategy Outlines for portfolio. Qualifications & Experience Requirements Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree in a related field or MBA is preferred. Minimum of 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products. Experience in working in teams with either a direct or matrix manager. Candidates have developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan). 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. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out.
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CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? This is a hybrid position and is onsite three days a week. You will report to the Executive Director Head Regulatory. Position Description Summary Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric-focus. Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners. Supporting, potentially leading, health authority interactions in stationed country (FDA or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities. Engaging GRAST members to achieve regulatory deliverables while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed. Main Responsibilities & Accountabilities As GRA representative, proactively contributes and builds effective relationships with respective members of Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and/or Device/EHT related development teams. Supports assigned product relationship with key health authorities (FDA & EMA), including CSL contact for home country and for content, plus approach, in all global health authorities. Single GRA reviewer, and as necessary approver, of deliverables generated from PST, CDT, SMT and related delivery teams. Lead GRA project deliverables and mentor GRAST members, as appropriate. Leverage GRAST, competitive regulatory intelligence/AI, business insights / analytics and other specialized regulatory functions to deliver Global Regulatory Strategy Outlines for portfolio. Qualifications & Experience Requirements Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree in a related field or MBA is preferred. Minimum of 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products. Experience in working in teams with either a direct or matrix manager. Candidates have developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan). 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. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out.
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