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Urgent! Senior Manager Regional Regulatory Lead, (IG/EHT) - US (Ig/EHT) Job Opening In King of Prussia – Now Hiring CSL
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, leveraging appropriate business insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.•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 (including assign tasks) while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed.Within GRAST, effectively foster two-communication between GRAST and R&D teams (e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globallyMain 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, including critical partners, in research, clinical development, commercial development, business development, project management and Global Product Leads (GPLs) ensuring a bi-directional dialog.•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.For non-home country health authority, works together with TA RRL with respective health authority to achieve objectives and as needed, Regulatory TA Head to escalate topics within agencies.•Single GRA reviewer, and as necessary approver, of deliverables (e.g. protocol, TPP, etc.) generated from PST, CDT, SMT and related delivery teams.May lead discussion at Global Regulatory Forum (GRF) or with senior management on projects.•Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members, as appropriate•Leverage GRAST, competitive regulatory intelligence/AI, business insights / analytics and other specialized regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio•Fosters and promotes effective relationships across Global Regulatory Strategy to ensure consistency, common approach, and shared learnings.Qualifications & Experience Requirements
•Bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required.An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred.Our Benefits
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Unlock Your Senior Manager Potential: Insight & Career Growth Guide
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Great news! CSL is currently hiring and seeking a Senior Manager Regional Regulatory Lead, (IG/EHT) US (Ig/EHT) to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at CSL adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Manager Regional Regulatory Lead, (IG/EHT) US (Ig/EHT) Jobs United States varies, but the pay scale is rated "Standard" in King of Prussia. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
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