Senior Manager Regional Regulatory Lead, (IG/EHT) - US (Ig/EHT)

Job Details
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, IG/EHT (Enabling Healthcare Technologies encompasses complex medical devices with clinical development, software as a medical device and companion diagnostics)? The job is in our King of Prussia, PA office. 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, 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 globally
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, 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. Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.• Applies the CSL Leadership Capabilities - Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent - to oneself.
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. • 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. Assesses preferred option for tough decisions.• 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)• Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health authority.• Relevant experience working in a complex and matrix environment is preferred. Ideal candidates will have a relevant clinical or device foundation#LI-HYBRID
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 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 use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
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. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL .
Do work that matters at CSL Behring!
Company
CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
Areas of Expertise
We focus and demonstrate global leadership in three distinct areas-rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.
Rare & Serious Diseases
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.
Vaccines
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.
Iron Deficiency & Nephrology
With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives.
Company info
Phone Location 1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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