Senior Director, Group Regulatory Team Leader – EHT

Job Description

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 Director, Group Regulatory Team Lead, EHT? 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.

Position Description Summary

•Member of the GRA Global Regulatory Strategy Leads Team (GRSLT) •Regulatory leaders who develop a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned portfolio with a strong patient centric-focus, leveraging appropriate business acumen and prudent risk-taking to ensure effective, 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. •Leader of a team of Global Regulatory Leads and/or Regional Regulatory Leads at CSL’s global facilities that support life-cycle management activities or Enabling Healthcare Technologies (EHT).  Coaches and ensures effective talent development and career growth of the team.

Main Responsibilities & Accountabilities

•Proactively builds, fosters and promotes effective relationships with GRSLT members to ensure consistency, common approach, and shared learnings amongst department. Actively connects and maintains relationships with GRASLT, GRA Regional LT and Regulatory CMC LT members.. •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. •Engage 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-way communication between GRAST and R&D teams (e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globally.  As needed, lead GRA project deliverables (e.g. Core Briefing Books, GRSO, etc.).•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, coaches direct report on effective interaction strategies with respective health authority and as needed, leverages Regulatory TA Head to escalate topics within agencies..•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•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, may participate in regulatory due diligence / div