Director Senior Global Regulatory Lead

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 Director Senior Global Regulatory Lead? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to the Executive Director Head Regulatory.

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:

· Regulatory leaders who develop a global, integrated regulatory strategy ensuring innovative, scientificallyc 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 from early development through registration and subsequent post-marketing life-cycle activities.

· 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.

· Directly leading health authority interactions in stationed country (FDA or EMA) and building 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.

· For select roles, manager of Regional Regulatory Leads at CSL’s global facilities that support assigned product/s or TA related products. Coaches and ensures effective talent development and career growth of the team.

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.

2 Accountable for assigned product strategic 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.

3 Single GRA reviewer, and as necessary approver, of deliverables (e.g. protocol, TPP, etc.) generated from PST, CDT, SMT and related delivery teams. In conjunction with Reg TA Head, participate in regulatory due diligence / divestiture activities for therapeutic area(s) or functional area. Lead discussion at Global Regulatory Forum (GRF) or with senior management on projects.

4 Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members, as appropriate.

5 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.

6 Proactively promotes effective relationships across Global Regulatory Strategy to promote consistency, common approach, and shared learnings. Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.

7 For select roles with direct reports, mentors/coaches team members to develop innovative, courageous solutions to potential challenges, apply enterprise mindset and prudent risk-taking in strategy development while ensures on-time execution plus delivery to bring assigned therapies/indications/products to patients. Fosters team development to articulate and communicate with teams/ senior leaders the regulatory perspective.

8 Applies the CSL Leadership Capabilities – Build Bridges, Think Bey