Director, Sr. Global Regulatory Lead
- Regulatory leaders, who craft and drive development of scientifically sound, prospective, global regulatory strategies for a product portfolio, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome
- Represent GRA on multi-product Product/Project Strategy Teams (PSTs), Clinical Development Teams (CDTs), Safety Management Teams (SMTs), Evidence Access Strategy Team (EAST) and internal governance meetings (e.g. TPRC/TALT) as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective portfolio.
- As GRAST Leader, leverage the GRAST members to achieve regulatory deliverables (including assign tasks), act as decision maker for team as needed, assess plus communicate regulatory outcomes and fosters review/discussion, plus ultimately approves, project related deliverables (e.g. GRSO, TPP, TPC, Protocol, CCDS, CTD clinically related sections) for the Team.
Accountabilities:1.Actively contributing as a Full-Time GRA Member for respective product portfolio teams (e.g. PST, CDT, SMT, TMI Project) and articulating sound, regulatory input/perspective into product strategy2.Effectively leading the product portfolio GRASTs, utilizing full GRAST membership, to prudently and expeditiously deliver global regulatory submissions throughout development, including partnering with respective Regulatory Project Manager to ensure on-time delivery.3.Lead GRA project deliverables (e.g. Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members, as appropriate.4.Facilitate reviews and be respective GRA reviewer signatory for CTD clinical/safety documentation (development/registration).5.Partner and actively support GRA Region in product portfolio health authority interactions globally and participate in overall product/clinical/safety related interactions.6.Ensure bi-directional communication between product (e.g. PST/CDT) and GRA teams (GRAST/GRA TA Team) on product related activities (scientific/business/patient), including driving management communication for GRA activities.7.Leverage GRAST, competitive regulatory intelligence/informatics, business insights / analytics and other specialized regulatory functions (e.g. device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.
Qualifications:Education: Minimum 4-year university degree (or equivalent) in scientific field (e.g. biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree preferred (e.g. PhD, MS, MBA). Experience: 12+years biotech/ pharmaceutical industry, 8 years regulatory experience, including 5 years in development. Direct agency interaction experience, preferably ICH regions. Team leadership experience, preferably 5 years as direct or matrix manager. Clinical (or Device/Combination Product) regulatory experience preferred. Exposure to market access activities is preferred. Competencies: Strong scientific and ethical foundation. Consistently applies Servant Leadership and Team Player principles to team environment, including leading without authority. Strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks. Builds and works effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes. Prior experience mentoring junior staff members in regulatory affairs. Fluent in English (written & verbal). About Us
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